Full-Time
Quality Assurance Team Lead
ANI Pharmaceuticals
501-1,000 employees
Develops, manufactures, markets prescription drugs
Compensation Overview
$80k - $100k/yr
East Windsor, NJ, USA
In Person
Bachelor's
 Biology & Biotech (1) |
|---|
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- A bachelor's degree is required.
- At least 5 years of experience in a Good Manufacturing Practice or Quality Assurance environment is required.
- Demonstrated ability to coordinate multiple tasks and priorities.
- Ability to read, interpret, and enforce Standard Operating Procedures.
- Strong attention to detail and organizational skills.
- Ability to work effectively within a team environment.
- Flexibility to support shift changes as needed.
- Strong verbal and written communication skills.
- Leadership, coaching, and team development capabilities.
- Ability to work in a fast-paced, dynamic environment.
- Strong problem-solving and decision-making skills.
- Excellent interpersonal and collaboration skills.
- Working knowledge of Good Manufacturing Practice requirements and Quality Assurance processes.
- Perform packaging line inspections and audits and ensure compliance with Standard Operating Procedures and Good Manufacturing Practice requirements.
- Conduct finished product inspections and evaluate physical characteristics before packaging.
- Perform in-process checks during packaging to ensure adherence to batch record specifications.
- Review batch documentation and ensure compliance with established procedures.
- Monitor Good Manufacturing Practice areas for compliance with 21 CFR guidelines and internal standards.
- Perform raw material and packaging material sampling.
- Collect stability samples, coordinate testing, and support stability programs.
- Prepare stability protocols and assist in compiling reports.
- Perform annual retain sample inspections and manage reserve sample inventory.
- Identify and escalate quality issues, deviations, and potential risks.
- Provide day-to-day oversight and guidance to Quality Assurance Associates.
- Assign and prioritize work based on production schedules and departmental needs in partnership with Quality Assurance leadership.
- Review team output for accuracy, completeness, and compliance with Good Manufacturing Practice standards.
- Support hiring, onboarding, and training of Quality Assurance team members.
- Approve employee time off and manage scheduling and coverage.
- Conduct performance management activities, including mid-year and year-end reviews.
- Coach and develop team members and provide ongoing feedback and career development support.
- Partner with cross-functional Manufacturing, Packaging, and Quality Control teams to resolve quality issues and improve processes.
- Lead or senior experience in a Good Manufacturing Practice or Quality Assurance environment is preferred.
ANI Pharmaceuticals develops, manufactures, and markets prescription medications, including generic and branded products, that are FDA-approved. Its medicines are produced in regulated facilities and go through standard safety and efficacy testing to meet patient needs. The company sells these products to pharmacies, hospitals, and healthcare providers, using a portfolio that spans generic drugs and specialty branded therapies. What sets ANI apart is its combination of a diversified product lineup with growth through strategic acquisitions to expand its offerings and market reach, rather than relying on a single product area. Its goal is to provide high-quality medicines to patients while continuously expanding its portfolio and market presence through acquisitions and manufacturing capabilities.
Company Size
501-1,000
Company Stage
IPO
Headquarters
Baudette, Minnesota
Founded
1996
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Simplify's Take
What believers are saying
- Q2 2026 revenue hit $266 million, and management reaffirmed $1.08-$1.14 billion guidance.
- July 2026 was the highest month for new Cortrophin cases, signaling demand acceleration.
- Repurchased-capable cash generation reached $360.2 million, funding acquisitions and buybacks through May 2029.
What critics are saying
- Cortrophin 2026 guidance fell to $520-$540 million, exposing second-half execution risk.
- Merck royalty burden stays in the high-20% range, compressing Cortrophin margins.
- CG Oncology litigation still lingers after the July 29, 2025 no-damages verdict, risking distraction.
What makes ANI Pharmaceuticals unique
- Cortrophin Gel drove 43.5% Q2 2026 growth, with rare disease becoming ANI's core.
- ANI pairs U.S. manufacturing with 116 products, supporting branded, generic, and specialty breadth.
- Henry Gosebruch joined August 19, 2026, bringing AbbVie M&A discipline to transformation.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
Unlimited Paid Time Off
Paid Vacation
Paid Holidays
Employee Stock Purchase Plan
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↓ -3%2 year growth
↑ 23%ANI Pharmaceuticals trades at $76.15 per share, showing a 3% return over six months, underperforming the S&P 500's 11.7% gain. The company develops, manufactures, and markets branded and generic prescription pharmaceuticals with a portfolio of 116 products. The pharmaceutical firm demonstrated strong momentum with revenue growing at 35.6% compound annual growth rate over five years. Its free cash flow margin expanded by 38.5 percentage points during the same period, reaching 17.7% over the trailing 12 months. However, ANI Pharmaceuticals faces scale challenges with just $978.4 million in revenue over the past year. This smaller size limits its ability to build customer trust in the heavily regulated healthcare sector, though it allows for faster potential growth with proper execution.
ANI Pharmaceuticals, a developer and marketer of branded and generic prescription drugs with a focus on rare disease treatments, stands out among Russell 2000 stocks. The company's portfolio includes 116 pharmaceutical products. ANI delivered 34.7% annual revenue growth over the past two years, indicating market share gains. Earnings per share increased 19.9% annually over five years, outperforming peers. The company's free cash flow margin improved by 38.5 percentage points over five years, providing resources for growth initiatives, share buybacks, or dividends. Meanwhile, fashion retailer Revolve and hydraulic fracturing services provider ProPetro face challenges. Revolve's 6.6% annual sales growth and 6.5% customer growth over three years underperformed, whilst high marketing expenses suggest heavy spending on customer acquisition. ProPetro's modest revenue base and declining EBITDA margin limit its competitiveness.
ANI Pharmaceuticals has appointed Henry Gosebruch to its board of directors, effective 19 August 2026. Gosebruch brings over 30 years of experience in corporate strategy, business development, and finance across the biopharmaceutical sector. He currently serves as chief executive officer of Lakefront Biotherapeutics and previously held leadership positions at Neumora Therapeutics and AbbVie, where he oversaw more than 100 transactions including AbbVie's acquisition of Allergan. Before that, he spent over 20 years at J.P. Morgan as co-head of North American M&A. The appointment aims to strengthen ANI's board as the company accelerates its transformation into a rare disease-focused business. Muthusamy Shanmugam has resigned from the board but will continue as head of research and development and chief operating officer of New Jersey operations.
ANI Pharmaceuticals reported second-quarter revenue of $266 million, beating analyst estimates of $259.8 million with 25.9% year-on-year growth. The company's adjusted EPS of $2.21 also surpassed expectations of $2.04. Despite strong performance in rare disease and generics businesses, the market reacted negatively to the results. CEO Nikhil Lalwani highlighted momentum in the third quarter, noting July marked the highest month for new cases initiated. The company reconfirmed its full-year revenue guidance of $1.11 billion at the midpoint and maintained its adjusted EPS guidance of $9.44. Operating margin improved to 15.2%, up from 6.6% in the same quarter last year. Analysts questioned the disconnect between prescription data and revenue, insurance reverification issues, and the rationale behind lowering Cortrophin guidance despite positive demand metrics.
ANI Pharmaceuticals reported Q2 revenues of $266 million, up 25.9% year on year, exceeding analyst expectations by 2.4%. The company beat EPS estimates but slightly missed full-year revenue guidance expectations. Despite posting the fastest revenue growth among the four generic pharmaceuticals stocks tracked, ANI's shares fell 9.1% following the results. The company's portfolio includes 116 pharmaceutical products with a focus on rare disease treatments. Generic pharmaceuticals companies as a group delivered strong Q2 results, with revenues beating consensus estimates by 2.6%. However, the sector has struggled recently, with share prices down 5.6% on average since the latest earnings announcements. The industry faces pricing pressures and thin margins but benefits from consistent demand for affordable medications.