QA Batch Review Specialist
About The Position
The QA Specialist - Batch Review supports Quality Assurance programs and the timely release of manufactured products. Working closely with the QA Supervisor, the role reviews and dispositions batch records, supports quality systems, and identifies operational and quality gaps. The specialist champions INCOG BioPharma's quality culture, emphasizing efficiency, attention to detail, compliance, and on-time delivery in a fast-paced GMP environment. The position requires independent decision-making and collaboration with cross-functional stakeholders, clients, and regulatory partners. The role performs full-lifecycle review and disposition of parenteral manufacturing batch records for formulation, filling, inspection, and packaging activities involving media fills and drug product. It supports batch release and investigations, oversees compliance activities, authors and approves GMP documentation, trains QA colleagues, analyzes site trends, and uses electronic and paper-based quality systems while ensuring data integrity. It also collaborates with Operations, Quality Control, Engineering, Validation, and clients, and promotes safety, operational excellence, teamwork, and customer success. Unless otherwise specified, positions are based at INCOG BioPharma's Fishers, Indiana offices. The campus is smoke-free. Applicants must be authorized to work in the United States on a full-time basis; the company will not sponsor work authorization or visas for this role.
Requirements
- Bachelor's degree required, preferably in a scientific discipline such as Chemistry, Biology, Biochemistry, Microbiology, or a closely related field.
- At least 4 years of experience in a GMP-regulated environment.
- At least 2 years of experience supporting aseptic processing within cleanroom and/or isolator environments.
- Strong understanding of pharmaceutical manufacturing processes and batch review practices.
- 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.
- Must be authorized to work in the United States on a full-time basis; visa or work authorization sponsorship is not provided.
Nice To Haves
- At least 3 years of experience working with Quality Management Systems, including Document Management Systems (DMS), Deviations/CAPA, and Change Control.
- At least 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.
Responsibilities
- 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 clients access and support during batch record review and approval processes.
- Partner with Quality Systems and Operations to support timely batch release activities.
- Create and report batch release metrics to site leadership.
- Advise on and approve batch record Bills of Material (BOMs) and Engineering Change Orders (ECOs).
- 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 assess 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.
- Train QA Associates and Specialists on surveillance oversight and on-the-floor batch record review requirements.
- Support quality initiatives that improve operational efficiency, compliance, and product quality.
- Analyze site trends using technical and statistical tools to identify variability sources and process improvement opportunities.
- Promote a strong quality mindset and a culture of continuous improvement.
- Use electronic and paper-based quality systems and ensure data integrity and compliance with site procedures, quality standards, and regulatory requirements.
- Balance production schedules with quality and compliance requirements.
- Collaborate with Operations, Quality Control, Engineering, Validation, and client teams.
- Manage multiple priorities and projects in a fast-paced manufacturing environment.
- Demonstrate a proactive commitment to safety, practice positive intervention, and enforce SOPs, quality requirements, and site expectations.
- Support a culture focused on operational excellence, teamwork, and customer success.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
