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INCOG BioPharma Services · 2 months ago

QA Manager, Batch Review and Disposition

Fishers, IN

Full-time

Onsite

Senior Level

6+ years exp

INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, focused on building long-term value for customers. The Quality Assurance Manager will lead batch review processes, make critical disposition decisions, and ensure compliance with regulatory requirements while fostering a culture of quality and precision.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

Lead comprehensive batch record review processes for sterile injectable drug products, ensuring completeness, accuracy, and compliance with approved manufacturing procedures and specifications

Make critical batch disposition decisions (release, reject, or investigate further) based on thorough evaluation of manufacturing data, in-process testing results, and finished product testing

Establish and maintain batch review procedures that ensure timely and accurate evaluation of all manufacturing batches while maintaining the highest quality standards

Lead investigation of manufacturing deviations and out-of-specification results, determining impact on product quality and appropriate corrective and preventive actions

Collaborate with Quality Control to review analytical testing data, certificate of analysis information, and trending of quality attributes across multiple batches

Partner with Manufacturing Operations to review batch execution data, process parameters, environmental monitoring results, and equipment performance records

Ensure compliance with cGMP requirements and regulatory expectations for batch review and release, maintaining detailed documentation of all disposition decisions

Develop and maintain batch review checklists and standard operating procedures to ensure consistent and thorough evaluation processes

Lead cross-functional batch review meetings to discuss complex cases, unusual events, and trending of quality data across product lines

Maintain batch disposition databases and generate reports on batch release metrics, cycle times, and quality trends for senior management

Ensure readiness for regulatory inspections by maintaining comprehensive batch files and being prepared to justify all disposition decisions to regulatory authorities

Train and develop team members on batch review processes, quality systems, and regulatory requirements specific to sterile injectable products

Utilize electronic batch record systems and quality management systems (Veeva, LIMS, etc.) to ensure data integrity and efficient review processes

Apply statistical analysis to identify trends in manufacturing performance and product quality, implementing continuous improvement initiatives

Stay current with regulatory guidance on batch review and release requirements from FDA, EMA, and other global regulatory authorities

Qualification

CGMP requirementsBatch review processesRegulatory inspectionsElectronic quality systemsAnalytical skillsStatistical analysisProject managementContinuous improvementProblem-solving skillsAttention to detailTeam leadership

Required

Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)

Minimum of 6 years of Quality Assurance experience in pharmaceutical manufacturing with at least 4 years focused on batch review and disposition

Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing

Experience with regulatory inspections and ability to defend batch disposition decisions to regulatory authorities

Proficiency with electronic quality systems including LIMS and document management systems

Excellent analytical and problem-solving skills with demonstrated ability to make risk-based quality decisions under time pressure

Strong project management skills with ability to prioritize multiple batch reviews while meeting customer delivery commitments

Exceptional attention to detail and ability to identify potential quality issues that may not be immediately obvious

Preferred

Hands-on experience with aseptic manufacturing Quality

Isolator-based aseptic processing experience

3+ years of experience as a people leader or supervisor

Experience with building processes and procedures

Experience with Continuous improvement, Six Sigma, and/or Lean principles

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees