QA Specialist (Batch Record Review)

Waltham MA

Pay $56-$61/hr

REQUIRED:

BS Degree

5 years of experience within Pharmaceutical/Biotech/Medical Device and 2 years of experience with executing batch record review - i.e: 'release of material' - 'product disposition' - 'release of material to commercial'

The manger would prefer internal batch records, but would take external (batch records w/ TPM - third party manufacturer - and CMO - commercial manufacturing organization)

Prefers stronger SAP - but any experience releasing product in some type of ERP will do

Job Description:

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 Client 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 Client 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.