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QA Specialist II

Location: Billerica
Posted on: January 13, 2022

Job Description:

Job Summary

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.
Area of Responsibility
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

Work Conditions: Office Area
Manufacturing floor

Physical Requirements: Stand, walk, sit, use hands and fingers to handle or feel, talk or hear, stoop, kneel, crouch or crawl
Close vision
Operate computer/office machines
Gowning, wear safety glasses & gloves
Lift up to 10 lbs.

Travel Estimate Up to 5%
Education and Job Qualification
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

Minimum 2-4 years related experience preferably in pharmaceutical (manufacturing) environment, Quality Assurance, Quality Control and/or production, or FDA regulated industry
Working knowledge of cGMPs Standards
Experience in pharmaceutical environment (manufacturing and/or Quality)

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Keywords: SUN PHARMA, Billerica , QA Specialist II, Other , Billerica, Massachusetts

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