Product Quality Engineer - The Fountain Groups

ONSITE WALTHAM MA

Pay: $55-$60/hr

REQUIRED:

• Bachelor’s degree preferably in Engineering or Science
• 5+ years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
• Knowledge of GMP regulations and standards affecting pharmaceutical products
• CAPAs
• Raw material investigation
• Batch Record auditing
• Comprehensive knowledge and application of business and quality concepts
• Raw material specification, product specification, test methods, supplier change notification
• 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

Job Description:

Sr Quality Assurance Specialist

Waltham, MA

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 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 notifications. This function also is the primary person to audit batch records for product manufactured by TPM plants and enter required batch documentation into the EDMS and prepare product for disposition.

Responsibilities

• Maintains an effective liaison and cooperative relationship with other areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.

• Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by QA Operations.

• Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.

• Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.