QA Manager (Lexington, MA)
Location: Framingham, Massachusetts, United States
Sectors: Engineering & Validation
Job Type: Contract
Title: QA Manager
Duration: One year (possible extensions)
Location: Lexington, MA
- Assists with the prioritization and coordination of batch release activities, to prevent supply disruption.
- Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of batch documentation for review according to requirements and SAP inspection plans.
- Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into systems e.g. LabLIMS and SAP/BPR
- Prepare and review batch documentation for release, including upload of batch certificates to the repository.
- Archive batch documentation according to company and customer requirements.
- Perform Technical Release of products in SAP/BPR based on release certificates from Contract Manufacturers/ Suppliers
- Support other functions as needed with e.g. PQR preparation, deviations, change controls, and CAPA.
- Maintenance of product lists and Quality relevant SAP master data.
- Provides other support/input as needed to ensure the effective oversight of Contract Manufacturers/Suppliers and compliance of OncESSM procedure/processes with internal requirements, and GMP.
- Provides Quality oversight for Artwork changes for product manufactured in the US.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline
- Minimum 6 years of QA/QC experience in the pharmaceutical industry
- Demonstrated teamwork, initiative, and problem-solving skills
- Fluent in English language oral/written communication skills
- Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
- Analytical Skills - ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
- Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management
- Proactiveness - ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
- Regulatory Understanding - broad based knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging
Sthree US is acting as an Employment Business in relation to this vacancy.