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QA Lot Specialist

The Quality Assurance Specialist, Lot Disposition, has responsibility for reviewing executed batch records, evaluating product deviations and drawing conclusions as to product disposition for material manufactured both internally and externally. The successful candidate will work closely with Quality Management, Manufacturing and Contract Organizations to identify strategies, tactics and objectives for product quality and GMP compliance.
Key Responsibilities
1
Conducts record review of executed batch records for vector and drug product lots.
2
Opens deviations and investigations as appropriate based on CMC and/or CMO notification; provides evidence of document closing at time of product disposition.
3
Assures all Quality events, change controls, CAPAs and/or other required documentation related to the product lots are completed and closed prior to material/lot release.
4
Works with CMOS/CTLs to ensure timely delivery of documentation/materials.
5
Prepares certificates of compliance (CoC) and certificates of analysis (CoA) for products for clinical and/or commercial materials; Audits vendor certificates (e.g. CoA, CoC) for completeness and compliance against approved specifications.
6
Evaluates analytical results against approved specifications to determine compliance; releases material for use and/or provides an appropriate disposition for products.
7
Develops process/procedures for release in conjunction with CMC personnel.
8
Evaluates lot test results against trending data to identify any irregular behavior.
9
Evaluates environmental monitoring results for conformance with ICH requirements in support of lot release.
10
Assists in the audits of contract manufacturers and contract laboratories for GMP compliance.
11
Support in the preparation for regulatory submissions and inspections, as needed.
Qualifications & Experience
Describe required and desirable educational requirements, experience and qualifications.
Required
Bachelor's Degree in a scientific discipline.
Minimum of 5 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
Solid technical writing skills related to investigation reports.
Broad knowledge of GMP, ICH and FDA/EMA regulations
Broad knowledge of Quality Systems, such as Change Control, Investigations, and CAPA
Excellent writer including but not limited to SOPs and reports
Desirable
Demonstrated knowledge of document control systems, preferably electronic systems
Skills & Competencies
Describe required and desirable skills and competencies needed to successfully perform the role.
Required
Excellent written and verbal skills
Ability to work and communicate internally and externally
Strong attention to detail
Desirable
Able to manage multiple priorities
Excellent problem solving skills
Able to exercise judgment to determine appropriate corrective actions

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