Supervisor, Quality Assurance
POSITION SUMMARY
The Quality Operations Supervisor leads a team of QA Specialists. The individual is responsible for the oversight as well as participation in the day-to-day Quality Operations activities which includes the disposition of in-process materials and final product packaging and release. The individual must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.
ESSENTIAL FUNCTIONS
Staff Management
Department Management:
- Establish and report applicable department or organizational metrics which drive accountability.
- Accountable for project completions and achievement of compliance goals.
- Represent department in project team meetings.
- Interact with project teams and cross-functional groups.
- Address and/or escalate site compliance problems and issues.
- Lead and facilitate meetings/workshops.
Additional Responsibilities:
- Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
- Ensure operations documentation meets established requirements for cGMPs, internal SOPs, and company policies.
- Conduct review of testing results in support of release of intermediates and final product.
- Assist in deviation/nonconformance identification and resolution.
- Participate and/or help lead root cause analysis to investigate deviations to determine appropriate root cause and CAPAs and may be responsible for CAPA resolution.
- Initiate, lead, and act as SME for change controls.
- Able to independently make decisions on intermediate issues and escalating major issues to Senior Management
- Perform validation protocol or final report review to ensure validation criteria and results are appropriate and comply with regulations and current industry standards.
- Interpret complex, explicit documentation to ensure quality standards and compliance are met.
- Provide training to new employees.
- Review and approve deviations, in support of product release.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
- Bachelor's degree or equivalent in related field or the equivalent combination of education and/or experience.
- 5+ years or more of increasingly complex quality assurance or manufacturing experience in the Biotech / Pharmaceutical industry.
- Strong interpersonal skills and ability to work in a team environment.
- Through knowledge of cGMP regulations
- Experience directly managing employees
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, validation, and process development.
- Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWise and Veeva).
- Ability to interpret Quality standards for implementation and review.
