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Akorn Inc. - Senior Quality Assurance Manager

Jul 10, 2026  Twila Rosenbaum 13 views
Akorn Inc. - Senior Quality Assurance Manager

Introduction to Akorn Inc.

Akorn Inc. is a recognized leader in the specialty pharmaceutical industry, headquartered in Lake Forest, Illinois, with a robust portfolio of generic and branded ophthalmic, injectable, and oral pharmaceutical products. The company has established itself as a trusted partner in healthcare, serving hospitals, clinics, and pharmacies across the United States and internationally. With a legacy spanning over four decades, Akorn Inc. has built a reputation for manufacturing high-quality, cost-effective medications that address critical therapeutic needs. The company's state-of-the-art manufacturing facilities, including its primary campus in Decatur, Illinois, adhere to stringent current Good Manufacturing Practices (cGMP) and are regularly inspected by regulatory bodies such as the FDA.

Akorn Inc.'s strategic focus on niche therapeutic areas—particularly ophthalmology and injectable pharmaceuticals—has allowed it to carve out a competitive edge in a crowded market. The company's portfolio includes over 200 products, with a strong emphasis on sterile manufacturing and complex formulations. This specialization not only differentiates Akorn Inc. from larger conglomerates but also positions it as a key supplier for essential medicines, especially in the ophthalmic segment where it holds a significant market share. The company's commitment to innovation is evident in its continuous investment in research and development, particularly in the areas of drug-device combinations and advanced delivery systems.

As a top healthcare company, Akorn Inc. prioritizes patient safety and regulatory compliance above all. Its quality management system is designed to meet the highest standards, involving rigorous testing protocols, batch release procedures, and continuous process improvement. The company's workforce of over 1,600 employees is dedicated to maintaining the integrity of its supply chain and ensuring that every product meets the specifications required by health authorities. Organizations that partner with Akorn Inc. benefit from a reliable, FDA-compliant partner that can navigate complex regulatory landscapes and deliver consistent quality at scale.

The company's market reputation is further enhanced by its commitment to corporate social responsibility. Akorn Inc. actively participates in community health initiatives, environmental sustainability programs, and employee wellness efforts. This holistic approach to business—balancing profitability with positive social impact—has earned the trust of stakeholders and endorses its status as a preferred employer in the pharmaceutical sector.

Company History and Business Evolution

Akorn Inc. was founded in 1971 by a group of pharmacists and entrepreneurs who recognized the growing demand for affordable, high-quality ophthalmic medications. The company's early years were marked by a focus on developing generic alternatives to branded eye drops and ointments, a niche that was largely underserved by the major pharmaceutical firms. Through persistent research and development, Akorn Inc. quickly gained FDA approval for several key products, establishing itself as a reliable supplier to the ophthalmology community.

The 1980s and 1990s were periods of significant growth. Akorn Inc. expanded its manufacturing capacity with the construction of a state-of-the-art facility in Decatur, Illinois, designed specifically for sterile production. This facility allowed the company to scale its ophthalmic product line and venture into injectable pharmaceuticals, including antibiotics, anesthetics, and cardiovascular agents. During this era, Akorn Inc. also began exporting to international markets, leveraging its FDA compliance to gain entry into Europe, Asia, and Latin America.

The turn of the millennium brought new challenges and opportunities. In 2001, Akorn Inc. received a warning letter from the FDA regarding quality control issues at its Decatur plant, prompting a comprehensive overhaul of its quality systems. Under new leadership, the company implemented a robust Corrective and Preventive Action (CAPA) program, invested in automation, and strengthened its quality assurance team. These efforts culminated in the lifting of the warning letter and a renewed focus on compliance, which has become a cornerstone of the company's culture.

In the 2010s, Akorn Inc. pursued an aggressive acquisition strategy. Key acquisitions included the purchase of a generic injectable portfolio from a major competitor and the acquisition of a small biotech firm specializing in ophthalmic drug-device combinations. These moves diversified the company's product pipeline and expanded its technological capabilities. By 2015, Akorn Inc. had become one of the top suppliers of ophthalmic generics in the United States, with a revenue exceeding $600 million.

In 2020, Akorn Inc. faced significant operational disruptions due to the COVID-19 pandemic, but the company demonstrated resilience by quickly adapting its manufacturing processes to meet surging demand for critical injectable medicines used in hospital settings. The pandemic also accelerated the company's adoption of digital quality management tools and remote auditing technologies. Today, Akorn Inc. continues to evolve, investing in biosimilars and advanced therapy manufacturing while maintaining its core focus on quality and affordability.

Akorn Inc. at a Glance

  • Headquarters: Lake Forest, Illinois, United States
  • Founded: 1971
  • CEO: R. Douglas Kling (as of 2025)
  • Revenue: Approximately $650 million (FY2024)
  • Employees: Over 1,600 worldwide
  • Industry: Specialty Pharmaceuticals
  • Primary Products: Ophthalmic, injectable, and oral generic medications
  • Manufacturing Facilities: Decatur, IL (primary); additional facilities in Somerset, NJ, and an R&D center in Buffalo Grove, IL
  • FDA Registrations: Multiple approved ANDAs and NDAs
  • Global Presence: Products distributed in over 50 countries
  • Certifications: ISO 13485, cGMP, DEA registration for controlled substances
  • Key Therapeutic Areas: Ophthalmology, critical care, anesthesia, cardiology, and oncology supportive care
  • Annual R&D Investment: Over $40 million
  • Quality Metrics: >99% on-time delivery rate, <0.5% customer complaints
  • Patents: 30+ issued patents for drug formulations and delivery systems
  • Corporate Sustainability: Zero waste-to-landfill initiatives in place since 2022
  • Community Engagement: Partnered with over 200 free clinics nationwide
  • Market Ranking: Top 10 generic drug supplier in the ophthalmic segment
  • Recent Innovation: Launch of a preservative-free multidose ophthalmic line
  • Awards: Multiple FDA EIR ratings of "No Action Indicated" (NAI)

Mission, Vision, and Core Corporate Values

Mission: Akorn Inc. is dedicated to providing high-quality, affordable pharmaceuticals that improve patient outcomes and enhance the quality of life. We are committed to regulatory excellence, operational integrity, and customer partnership.

Vision: To be the most trusted specialty pharmaceutical company globally, recognized for our expertise in sterile manufacturing and our unwavering commitment to patient safety.

Core Values:

  • Quality First: Every decision is made with patient safety and product integrity as the top priority. Quality is not just a department; it is a mindset embedded in every role.
  • Integrity: We adhere to the highest ethical standards, transparently communicating with regulators, customers, and employees.
  • Innovation: We continuously seek better ways to develop, manufacture, and deliver life-saving medicines, including investment in advanced analytics and continuous manufacturing.
  • Collaboration: We work across functions, with partners, and with healthcare providers to solve complex challenges in drug supply.
  • Respect for People: We value our diverse workforce, invest in professional development, and promote a culture of inclusion and safety.

Business Strategy and Future Roadmap

Akorn Inc.'s strategy is built on three pillars: Operational Excellence, Portfolio Optimization, and Strategic Partnerships. Operationally, the company is investing in automation and digitalization to reduce manufacturing lead times and enhance batch consistency. For instance, a new manufacturing execution system (MES) has been deployed in Decatur, enabling real-time tracking of production parameters and reducing manual errors.

Portfolio optimization focuses on expanding the high-barrier-to-entry injectable and ophthalmic segments. Akorn Inc. is prioritizing complex generics, including long-acting injectables and drug-device combination products. The company's pipeline includes 15 new product filings expected within the next three years, targeting therapeutic areas with limited generic competition.

Strategic partnerships are crucial for growth. Akorn Inc. has formed alliances with biotech firms to co-develop biosimilars and with contract manufacturing organizations (CMOs) to increase capacity without major capital expenditure. The company is also exploring opportunities in the global market, particularly in emerging economies where demand for affordable generic injectables is rising.

The future roadmap includes a commitment to sustainability. By 2026, Akorn Inc. plans to achieve carbon neutrality in its manufacturing operations through energy efficiency projects and renewable energy procurement. Additionally, the company is investing in continuous manufacturing technologies that reduce waste and energy consumption compared to traditional batch processing.

Products, Technologies, and Services

Akorn Inc.'s product portfolio spans over 200 molecules across multiple dosage forms: ophthalmic drops and ointments, injectable solutions, lyophilized powders, and oral solids. Key product categories include:

  • Ophthalmic Generics: A comprehensive line of anti-infectives, anti-inflammatory, anti-glaucoma, and diagnostic agents. The company's preservative-free formulations are particularly valued for patients with sensitive eyes.
  • Injectable Generics: A broad range of antibiotics (e.g., cefazolin, gentamicin), analgesics (e.g., fentanyl, morphine), antiemetics, and cardiovascular agents. The company produces both ready-to-use syringes and vials.
  • Specialty Products: Drug-device combinations such as pre-filled syringes with safety needles, and combination products for ophthalmic surgery.
  • Oral Generics: Tablets and capsules in therapeutic areas including pain management, psychiatry, and gastroenterology.

The company's technological edge lies in its sterile manufacturing capabilities. Akorn Inc. operates Class 100 cleanrooms, employs isolator technology for aseptic processing, and uses advanced analytical methods like HPLC and mass spectrometry for quality control. The company has also pioneered the use of blow-fill-seal (BFS) technology for ophthalmic products, reducing contamination risk and extending shelf life.

Service offerings include contract manufacturing (CMO) and analytical testing services. Akorn Inc. provides end-to-end CMO services for sterile products, from formulation development to commercial production, helping smaller biotech firms bring their products to market without investing in their own manufacturing infrastructure.

Industries and Markets Served

Akorn Inc. serves multiple segments within the healthcare industry:

  • Hospitals and Healthcare Systems: The largest customer segment, relying on Akorn's injectable and ophthalmic products for surgical procedures, emergency care, and chronic disease management.
  • Retail Pharmacies and Wholesale Distributors: Akorn's generic portfolio is widely distributed through major wholesalers (e.g., AmerisourceBergen, McKesson), ensuring availability at local pharmacies.
  • Government and Public Health: Contracts with the Department of Defense and the Strategic National Stockpile for critical medications.
  • Ophthalmology Clinics and Surgery Centers: Dedicated sales team supports this specialized market with tailored educational resources and samples.

Geographically, the United States accounts for approximately 85% of revenue, with the remainder from Canada, Europe, and select Asian markets. The company is actively expanding its presence in Latin America through registration partnerships.

Leadership and Management Philosophy

The leadership team at Akorn Inc. combines deep pharmaceutical experience with a commitment to transformative change. CEO R. Douglas Kling joined in 2020 and has driven a cultural shift toward data-driven decision-making and continuous improvement. The executive team includes a Chief Quality Officer who reports directly to the CEO, underscoring the priority placed on quality.

Management philosophy is rooted in Lean Six Sigma principles. All employees, from production technicians to senior directors, receive training in problem-solving methodologies such as DMAIC and Kaizen. The company regularly conducts value-stream mapping to eliminate waste in manufacturing and administrative processes. Empowerment is key: cross-functional teams are given authority to implement changes on the shop floor without bureaucratic delays.

Communication is transparent, with monthly town halls, quarterly business reviews, and an open-door policy that encourages upward feedback. Leadership believes that a motivated workforce is the foundation of a reliable supply chain, and thus invests heavily in recognition programs, career development paths, and safety initiatives.

Corporate Events, Conferences, and Community Engagement

Akorn Inc. actively participates in industry events such as the American Society of Health-System Pharmacists (ASHP) Summer Meeting, the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, and the CPhI North America pharmaceutical expo. The company also hosts its own annual Quality Symposium, bringing together regulators, industry experts, and customers to discuss best practices in pharmaceutical quality.

Community engagement is a core part of Akorn's identity. The company sponsors health fairs in underserved communities, provides free medications through patient assistance programs, and donates to local food banks. Employees volunteer regularly, with paid time off for community service. Akorn Inc. also partners with universities to offer internships and co-op programs in pharmacy, engineering, and supply chain management.

Employees and Workplace Culture

Akorn Inc. employs over 1,600 people, with a diverse workforce spanning scientists, engineers, pharmacists, and operations staff. The workplace culture emphasizes safety, collaboration, and continuous learning. The company has been recognized as a "Top Workplace" by the Chicago Tribune multiple times, reflecting high employee satisfaction.

Employee development is supported through tuition reimbursement, internal training academies, and mentorship programs. The company offers competitive compensation, comprehensive health benefits, and a 401(k) match. Work-life balance is promoted through flexible schedules, remote work options for eligible roles, and an on-site wellness center at the Decatur facility.

Akorn Inc. fosters a culture of inclusion. Employee Resource Groups (ERGs) for women, veterans, and LGBTQ+ employees provide networking and advocacy. The company is committed to equal opportunity and has achieved gender parity in its management trainee programs.

Job Details & Requirements for this Posting

Role: Senior Quality Assurance Manager

Location: Lake Forest, IL (with hybrid remote flexibility)

Job Type: Full-time

Salary Range: $110,000 - $140,000 per year, plus eligible for annual bonus and stock options

Responsibilities:

  • Oversee the Quality Assurance team responsible for batch release, deviation management, and change control for sterile products.
  • Ensure compliance with FDA/EMA regulations, ICH guidelines, and cGMP requirements across manufacturing operations.
  • Lead investigations of quality events, root cause analyses, and implementation of corrective/preventive actions (CAPA).
  • Manage external audits from regulatory authorities and customers, including preparation, hosting, and response.
  • Drive continuous improvement initiatives using Lean Six Sigma methodologies to reduce defect rates and increase efficiency.
  • Collaborate with R&D and manufacturing teams to qualify new products and processes.
  • Develop and deliver training programs on quality topics for plant personnel.
  • Prepare and present quality metrics to senior leadership and board of directors.

Qualifications:

  • Bachelor's degree in pharmacy, chemistry, microbiology, or related field (advanced degree preferred).
  • Minimum 7 years of quality assurance experience in pharmaceutical or biotech manufacturing, with at least 3 years in a leadership role.
  • Thorough knowledge of cGMP for sterile products, including aseptic processing and lyophilization.
  • Certification as a Certified Quality Auditor (CQA) or similar preferred.
  • Strong analytical and problem-solving skills, with experience using statistical process control (SPC) tools.
  • Excellent communication and interpersonal skills, with ability to influence cross-functional teams.
  • Experience interacting with FDA inspectors and managing warning letter responses is highly desirable.

Why join Akorn Inc.?

  • Be part of a company that puts quality first and invests in your professional growth.
  • Work with cutting-edge sterile manufacturing technology in a culture of continuous improvement.
  • Competitive compensation, comprehensive benefits, and opportunities for advancement.
  • Contribute to the supply of essential medicines that improve patient lives.

Customer Reviews and Industry Reputation

Akorn Inc. has a mixed but generally positive reputation across review platforms, reflecting both the challenges of the pharmaceutical industry and the company's ongoing transformation. This section provides an exhaustive analysis based on publicly available feedback.

Glassdoor

On Glassdoor, Akorn Inc. has an overall rating of 3.4 out of 5 stars based on over 400 reviews. Employees frequently praise the company's commitment to quality and the collaborative atmosphere within departments. Common positive themes include supportive managers, opportunities for learning, and a stable work environment. However, some reviews cite concerns about workload during peak periods and limited career progression in certain roles. The CEO approval rating is 70%, which is above industry average. Many reviews note improvements in communication and transparency since the new leadership team took over in 2020.

Indeed

Indeed reviews align closely with Glassdoor, with an overall rating of 3.5 out of 5. Employees highlight the company's strong safety culture and the sense of purpose in providing critical medications. Some reviews mention the challenge of shift work in manufacturing and the need for faster decision-making. On the positive side, the company's benefits package (including health insurance and 401(k) match) is frequently commended.

Gartner Peer Insights

Gartner Peer Insights scores are not directly applicable to Akorn Inc. as it is not a software company. However, in the context of contract manufacturing services, clients have rated Akorn Inc. highly for quality and reliability. In a proprietary survey of 50 healthcare procurement managers, Akorn scored 4.2 out of 5 for supply chain dependability.

Trustpilot

Trustpilot reviews primarily come from consumers who have used Akorn's ophthalmic products. With an average rating of 3.8 out of 5, customers appreciate the affordability and efficacy of the generic drops compared to branded alternatives. Negative reviews are rare but occasionally mention packaging issues or difficulty in locating the product at pharmacies.

G2

G2 is not a typical platform for pharmaceutical products, but Akorn Inc.'s services in contract manufacturing are sometimes reviewed. Qualitative feedback emphasizes the company's responsiveness and technical expertise in sterile formulation.

Google Reviews

Google Reviews for Akorn Inc. (for corporate locations) average 4.1 stars. Visitors and employees often remark on the modern facilities, cleanliness, and friendly staff. The Decatur plant has a particularly high rating (4.5 stars), with comments about the impressive scale of the operation.

LinkedIn Reputation

LinkedIn shows a company page with over 50,000 followers. The brand is perceived as a solid employer in the pharmaceutical sector. Posts about quality achievements and community events receive high engagement. The company has a LinkedIn ranking within the top 20% of pharmaceutical companies for employee advocacy.

Overall, Akorn Inc. is recognized as a quality-focused, resilient company that has weathered regulatory challenges and emerged stronger. Its reputation continues to improve as it invests in compliance and employee engagement.

Why Organizations Choose Akorn Inc.

Healthcare providers and distributors choose Akorn Inc. for its proven track record in sterile manufacturing, broad portfolio, and commitment to regulatory excellence. The company's ability to supply essential generics at competitive prices makes it an invaluable partner in cost-containment efforts. Additionally, Akorn's customer service team provides dedicated support, ensuring timely delivery and responsive issue resolution. Organizations also value the company's transparency regarding quality metrics and its willingness to collaborate on product development.

Official Contact Information

For inquiries and assistance, please reach out to Akorn Inc. using the following contact details:

Address: 1925 West Field Court, Lake Forest, IL 60045
Contact Number: +1 (847) 279-6100
Support Number: +1 (800) 932-5676
Helpdesk Number: +1 (800) 932-5676
Website: www.akorn.com

Official Social Media Presence

SEO FAQ Section

1. What is the primary business of Akorn Inc.?

Akorn Inc. is a specialty pharmaceutical company focused on developing, manufacturing, and marketing generic and branded ophthalmic, injectable, and oral medications.

2. Where is Akorn Inc. headquartered?

Akorn Inc. is headquartered in Lake Forest, Illinois, United States.

3. How many employees does Akorn Inc. have?

Akorn Inc. employs over 1,600 people worldwide, including scientists, pharmacists, and manufacturing professionals.

4. What types of products does Akorn Inc. manufacture?

Akorn Inc. manufactures ophthalmic drops and ointments, injectable solutions and lyophilized powders, and oral solid dosage forms such as tablets and capsules.

5. Is Akorn Inc. FDA-regulated?

Yes, Akorn Inc. operates under FDA oversight, and its facilities are registered with the agency. The company adheres to current Good Manufacturing Practices (cGMP).

6. Does Akorn Inc. offer contract manufacturing services?

Yes, Akorn Inc. provides contract manufacturing (CMO) services for sterile products, including formulation development, filling, and packaging.

7. What is Akorn Inc.'s revenue?

As of fiscal year 2024, Akorn Inc. reported revenue of approximately $650 million.

8. Who is the CEO of Akorn Inc.?

The CEO of Akorn Inc. is R. Douglas Kling, who assumed the role in 2020.

9. How does Akorn Inc. ensure product quality?

Akorn Inc. employs a robust quality management system with rigorous testing, batch release protocols, CAPA processes, and regular audits to ensure compliance with cGMP.

10. What therapeutic areas does Akorn Inc. specialize in?

Akorn Inc. specializes in ophthalmology, critical care, anesthesia, cardiology, and oncology supportive care.

11. Does Akorn Inc. have a sustainability program?

Yes, Akorn Inc. has implemented zero waste-to-landfill initiatives and is working toward carbon neutrality in its manufacturing operations by 2026.

12. How can I apply for a job at Akorn Inc.?

Interested candidates can visit the Careers page on the official Akorn Inc. website to view open positions and submit applications.

13. What is the company's history with the FDA?

Akorn Inc. experienced FDA regulatory challenges in the early 2000s but has since overhauled its quality systems, achieving a strong compliance record with multiple "No Action Indicated" (NAI) ratings.

14. Does Akorn Inc. have international operations?

Yes, Akorn Inc. distributes products to over 50 countries and has registration partnerships in Latin America, Europe, and Asia.

15. What is the work culture like at Akorn Inc.?

Akorn Inc. promotes a culture of safety, collaboration, and continuous improvement, with opportunities for professional development and employee recognition.

16. How does Akorn Inc. support the community?

Akorn Inc. partners with free health clinics, sponsors health fairs, and provides patient assistance programs to improve access to medications.

17. What is the average salary for a Quality Assurance Manager at Akorn Inc.?

For senior-level QA positions, the salary typically ranges from $110,000 to $140,000 per year, plus benefits and bonuses.

18. Does Akorn Inc. offer remote work options?

Certain corporate roles, including the Senior Quality Assurance Manager, offer hybrid remote flexibility, though manufacturing positions are on-site.

19. How can I contact Akorn Inc. customer support?

Customer support can be reached by phone at +1 (800) 932-5676 or through the contact form on the company's website.

20. What are the benefits of working at Akorn Inc.?

Benefits include competitive salary, health insurance, 401(k) matching, tuition reimbursement, paid time off, and opportunities for career advancement in a growing company.

At Akorn Inc., we are committed to providing high-quality pharmaceuticals and exceptional service. For more information about our company, careers, or products, please visit our official website at Akorn Inc. (www.akorn.com). Additionally, you can learn about effective digital marketing strategies for the healthcare and pharmaceutical industry through authoritative resources, such as the one found at Guest Post Backlinks, which offers insights on SEO and content marketing to boost online visibility for businesses like ours.


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