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Quality Documentation Specialist

Global Technical Talent

This is a Full-time position in Norwood, MA posted July 22, 2021.

                                                         Quality Documentation Specialist   The Role:
Our client is seeking a Specialist, Quality Assurance for a position based in their Norwood, MA facility.

The individual in this role will be responsible for providing Quality Assurance (QA) Documentation support for the client’s External QA team.

The individual will primarily work with: colleagues in External Quality as well as with Supply Chain Operations and logistics, Internal QA, CMC, and external Vendors to provide quality documentation support for the client’s External QA team.

This individual will support external QA by helping manage documents in the client’s quality document management system (Veeva), assist in collecting and archiving documentation, and support certain quality system activities.

Additionally, the individual will track and populate systems to maintain metrics and trends.

The successful candidate must have experience in managing documents in a quality document management system.

  Here’s What You’ll Do:
Review, approve and archive certain documents into the quality management system Collect, record, and archive documents in support of the external QA team Report on pending documents and help support retrieval of hard copy documents needing archiving Provide any other documentation support needed to ensure External QA is audit-ready Track Quality Systems including Change Controls and Deviations within client systems as well as at CMOS  

Job Requirements:
Here’s What You’ll Bring to the Table:
BS in a scientific or engineering discipline Minimum 4 years experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure Outstanding/effective communication skills (verbal and written) Ability to manage multiple projects in a fast-paced environment Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment Experience in the drug manufacturing and/or drug packaging and labeling processes Experience in SAP or similar ERP system Strong experience in Quality Document Management Systems including records and quality events Proficiency in Microsoft Office tools including Powerpoint, MS Project, and Visio Previous experience in a GMP environment is required