Massachusetts Jobs

QA Specialist II

Location MA, Billerica

Job Category Quality Assurance

Employment Duration Full time

Executes all activities involving quality assurance and compliance utilizing Current Good Manufacturing Practices (cGMP) requirements for pharmaceuticals and medical devices. Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and/or clinical products.

Responsibilities

• Review manufacturing batch records and quality control testing data for lot release and stability, ensuring conformance to approved procedures and cGMP

• Review SOPs, logbooks, and other documentation related to daily QA activities including raw material release.

• Perform QA coverage of GMP operations including manufacturing, labeling/packaging, QC testing, warehouse

• Perform walkthroughs of GMP areas documenting observations and areas of concern.

• Complete monthly QA metrics

• Perform line clearances in manufacturing areas including labeling/packaging

• Support internal audits of cGMP operating groups as necessary to ensure compliance to cGMP, internal procedures and policies

• Write and/or review Standard Operating Procedures

• Review and approve document change controls

• Review and approve CAPA, PRA and non-conforming product reports

• Execute continuous improvement projects as assigned

• Other duties as assigned

Qualifications

• Minimum 2-4 years related experience preferably in pharmaceutical (manufacturing) environment, Quality

• BS in life science preferred or equivalent related experience

• Works under limited supervision using independent judgment and exhibits strong attention to detail

• Good verbal, written and interpersonal skills

• Assurance, Quality Control and/or production, or FDA regulated industry

• Working knowledge of cGMPs Standards

• Experience in pharmaceutical environment (manufacturing and/or Quality)