QA Batch Review Specialist (Aseptic GMP) - 1st/2nd Shift

Lead Candidate Ltd; Fishers (IN); Vor Ort; USD 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Paid time off

11 paid holidays

401(k) plan with company match

Health & wellness plans

Onsite wellness facility

Team engagement activities

Zusammenfassung

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.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Communication skills

GMP experience

Aseptic processing

SCADA

Data analysis tools

Ausbildung

Bachelor's degree in science

Tools

SCADA

JMP

Minitab

Excel

Visio

Jobbeschreibung

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.