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About the Role
The QA Associate (Reviewer) is responsible for reviewing batch production records to ensure compliance with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role guarantees the integrity, accuracy, and completeness of batch records for pharmaceutical manufacturing, ensuring products meet approved methods and specifications.
Responsibilities
- Review batch production records (BPRs) and associated documents for completeness, accuracy, and GMP compliance.
- Verify proper documentation, signatures, and dates, and resolve discrepancies.
- Ensure batch records meet regulatory requirements from agencies like the FDA and EMA.
- Review, create, and revise BPRs, SOPs, and other manufacturing-related documents.
- Ensure batch records are audit-ready and compliant for internal and external audits.
- Assist audit teams by providing documentation and responding to queries.
- Recommend process improvements to enhance the batch review process and compliance.
- Address and resolve issues related to batch records raised by cross-functional teams.
- Ensure completion of assigned training and adherence to company policies, safety, cGMP, and SOPs.
- Review engineering records, including temperature and humidity data, calibration reports, and PMP records.
- Conduct daily Quality rounds on the shop floor to ensure GMP compliance.
- Report daily shop floor activities and discrepancies to the Manager of Quality Assurance.
- Perform other duties as assigned by management.
Requirements
- Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry.
- Strong knowledge of GMP, regulatory requirements (FDA, EMA), and pharmaceutical manufacturing processes.
- High attention to detail and accuracy in reviewing complex documentation.
- Strong communication skills and ability to collaborate effectively across departments.
- Familiarity with document management systems (e.g., Master Control).
- Ability to analyze and resolve batch documentation issues in a timely and efficient manner.
- Experience in preparing for regulatory inspections and audits.
- Excellent organization skills with the ability to focus on details.
- Strong organizational and time-management skills to handle multiple batch reviews simultaneously.
Skills
- Document management systems (e.g., Master Control)
- Batch documentation issue analysis and resolution
- Regulatory inspection and audit preparation
- Attention to detail
- Organizational skills
- Time-management skills
Location
- Hauppauge, NY
Work Type
- Onsite
- Full Time
Experience Level
- 2-3 years
Education Level
- Bachelor’s degree in pharmacy, Life Sciences, Chemistry, or a related field.
Salary/Compensations
- $66,300 - $86,000
Benefits
- 401(k) savings plan and matching
- Health insurance – medical/dental/vision
- Health savings account (HSA)
- Flexible spending account (FSA)
- Paid time off (PTO) - vacation/sick/flex time
- Paid holidays
- Short-term disability (STD)
- Long-term disability (LTD)
- Parental leave
- Paid and unpaid family leave
- Employee discounts
About the Company
- Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines, trusted by healthcare professionals and patients worldwide.
- With over eight decades of experience, Cipla has a strong leadership position in India and a significant global focus in key markets including South Africa, the U.S., and other emerging economies.
- Driven by the purpose 'Caring for Life', Cipla focuses on making affordable, world-class medicines with uncompromising quality standards.
- InvaGen Pharmaceuticals, a Cipla subsidiary, develops, manufactures, markets, and distributes generic prescription medicines across various therapeutic areas.
- InvaGen was founded in 2003 and operates in Central Islip and Hauppauge, New York, with an additional project site in Fall River, Massachusetts.
Equal Opportunity
- Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
- Cipla welcomes people of all abilities and ensures the hiring and interview process meets the needs of all applicants.
- Reasonable accommodation is available for applicants requiring assistance during the application or interview process.