The QA Specialist - Batch Review plays a critical role in supporting key Quality Assurance programs and ensuring the timely release of manufactured products. Working closely with the QA Supervisor, this position is responsible for the review and disposition of batch records, support of quality systems, and identification of operational and quality gaps.
This role serves as a champion of INCOG BioPharma's quality culture, driving efficiency, attention to detail, compliance, and on-time delivery. The ideal candidate thrives in a fast-paced GMP environment, balances independent decision-making with teamwork, and effectively collaborates with cross-functional stakeholders, clients, and regulatory partners.
Batch Review & Product Release
- Perform full lifecycle review and disposition of parenteral manufacturing batch records for formulation, filling, inspection, and packaging activities for media fills and drug product.
- Provide client access and support during batch record review and approval processes.
- Support timely batch release activities by partnering with Quality Systems and Operations.
- Create and report batch release metrics to site leadership.
- Advise and approve batch record Bills of Material (BOMs) and Engineering Change Orders (ECOs).
Quality Oversight & Compliance
- Support investigations into manufacturing and quality events, including root cause determination and mitigation planning.
- Participate in investigations involving major and critical deviations.
- Conduct preliminary evaluations of deviating events to determine impact, product segregation requirements, and immediate corrective actions.
- Escalate significant issues to management when appropriate.
- Support deviation investigations through root cause analysis, risk assessments, report writing, and mitigation development.
- Review plant automation alarms and support quality oversight activities.
- Author, review, and approve SOPs, work instructions, and related GMP documentation.
Training & Continuous Improvement
- Train QA Associates and Specialists on surveillance oversight and on-the-floor batch record review requirements.
- Support quality initiatives aimed at improving operational efficiency, compliance, and product quality.
- Analyze site trends using technical and statistical tools to identify sources of variability and process improvement opportunities.
- Promote a strong quality mindset and culture of continuous improvement.
Systems & Data Integrity
- Utilize electronic and paper-based quality systems, including:
- eDMS
- SCADA
- BMS
- CMMS
- LIMS
- Laboratory Instrument Software
- Ensure data integrity and compliance with site procedures, quality standards, and regulatory requirements.
Cross-Functional Collaboration
- Balance production schedules with quality and compliance requirements.
- Collaborate effectively with Operations, Quality Control, Engineering, Validation, and client teams.
- Influence positive outcomes through strong partnerships and technical expertise, regardless of reporting structure.
- Manage multiple priorities and projects in a fast-paced manufacturing environment.
Safety & Culture
- Demonstrate a proactive commitment to safety.
- Practice positive intervention and enforce compliance with SOPs, quality requirements, and site expectations.
- Support a culture focused on operational excellence, teamwork, and customer success.
Qualifications
Education
- Bachelor's degree required, preferably in a scientific discipline such as:
- Chemistry
- Biology
- Biochemistry
- Microbiology
- Or a closely related field
Experience
- Minimum 4 years of experience in a GMP-regulated environment.
- Minimum 2 years of experience supporting aseptic processing within cleanroom and/or isolator environments.
- Strong understanding of pharmaceutical manufacturing processes and batch review practices.
Skills & Knowledge
- Excellent written and verbal communication skills.
- Strong organizational and time management abilities.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Proficiency with Microsoft Office applications and quality/manufacturing systems.
- Experience with computerized manufacturing systems such as SCADA.
- Experience using data analysis and reporting tools such as Excel, Visio, JMP, or Minitab.
Preferred Qualifications
- 3+ years of experience working with Quality Management Systems, including:
- Document Management Systems (DMS)
- Deviations/CAPA
- Change Control
- 2+ years of experience reviewing Quality Control testing, Certificates of Analysis (CoA), and laboratory results.
- Extensive knowledge of product disposition processes and regulatory compliance requirements within a pharmaceutical manufacturing environment.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
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