QA Compliance Specialist III (Third Party Manufacturing

HYBRID WALTHAM MA

Pay : $49-$54 / hr

Work Schedule : M-F 8 : 00-5 : 00PM

REQUIRED :

• Bachelor's degree preferably in Engineering or Science
• Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
• Change notifications
• Batch Records
• Third Party Manufacturing
• Knowledge of GMP regulations and standards affecting pharmaceutical products
• Comprehensive knowledge and application of business and quality concepts
• Strong analytical skills and attention to detail
• Change plan, Exception Reports, SAP and LRMS experience is highly preferred
• Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
• Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization

The Senior Product Quality Assurance (PQA) Analyst has various objective / functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between Client regulatory areas and TPM plants for regulatory submission.

This function also is the primary person to audit batch records for product manufactured by TPM plants and enter required ba

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.