QA Batch Review Specialist

Lead Candidate; Fishers (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Paid time off

11 paid holidays

401(k) plan with company match

Health & wellness plans

Onsite wellness facility

Team engagement activities

Job summary

INCOG is seeking a QA Batch Review Specialist to oversee the review and disposition of Batch Records across formulation, filling, inspection, labeling and packaging, ensuring on-time batch release. You will train QA staff, support deviations, and drive quality metrics in a fast-paced, cGMP environment.

The role requires a bachelor's degree in a related science, 4+ years in GMP, and 2+ years in aseptic processing within cleanroom or isolator settings.

Qualifications

• Bachelor's degree in Chemistry, Biology, Biochemistry, Microbiology or related science field.
• 4+ years of experience in a GMP environment.
• 2+ years of experience with aseptic processing in cleanroom or isolator environments.
• Excellent written and verbal communication skills.
• Proficient with data analysis and reporting software (Word, Excel, Visio, JMP, Minitab).

Responsibilities

• Oversee full lifecycle review and disposition of Batch Records for parenteral manufacturing.
• Provide client access and support in batch record review and approval.
• Train QA Associates on surveillance and Batch Record review requirements.
• Support Quality Systems and timely closure of deviations impacting batch release.
• Create and report batch release metrics to site leadership.
• Participate in investigations for Major and Critical deviations.
• Assist in authoring, reviewing, and approving SOPs and Work Instructions.
• Advise on Batch Record BOMs and ECOs.
• Balance production timelines with product quality assurances.
• Exercise rapid decision-making on deviations and scope of impact.

Skills

Communication skills

GMP experience

Aseptic processing

SCADA

Data analysis tools

Education

Bachelor's degree in science

Tools

SCADA

JMP

Minitab

Excel

Visio

Job description

INCOG are looking for a QA Batch Review Specialist who will oversee review processes for Manufacturing Batch Record lifecycle activities, including Formulation, Filling, Inspection, Labeling and Packaging, and final-stage review and disposition at a new state-of-art contract development and manufacturing organization.

1st shift and 2nd shift available

What

Working closely with the QA Supervisor, the QA Batch Review Specialist will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The QA Specialist – Batch Review will at all times provide support with identifying and closing Operational and Quality gaps.

• Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
• Provide Client access and support in the review and approval of Batch Records.
• Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.
• Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities.
• Create and report batch release metrics to site leadership.
• Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events.
• Support authoring, reviewing and approving of various SOPs & Work Instructions.
• Advise and approve the builds of Batch Record BOMs and ECOs.
• Prioritize and coordinate their time in balancing production timelines with product quality assurances.
• Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or elevate the issue to Manager for resolution.

You!

• Bachelor’s Degree required or equivalent; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
• 4 years minimum experience working in a GMP environment.
• 2 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required.
• Excellent written and verbal communication skills.
• General computer skills evidenced by hands‑on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

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.

By submitting your resume and details, you are declaring that the information is correct and accurate.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.