QA Specialist job in Burlington, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Burlington, MA.

Job Responsibilities:

Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP's and our quality system to ensure real-time compliance
Represent our Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented
Review Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications
Monitor Operations personnel for adherence to SOP's. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement
Review and approve Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.) and batch records
Review and approve SOPs, test methods, raw material specifications, protocols and executed validation documentation
Author or revise SOPs
Perform manufacturing area and labeling clearances as well as inspection of material
Review and approve CAPAs, Deviations, Change Controls, Equipment Excursion Reports
Assist in performing investigations
Perform internal audits and weekly walkthroughs
External audits for Supplier qualification
With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
Assist in developing and delivering training
Assist tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
Develop and/or maintain Quality System metrics for Management Review
Provide on the floor support to manufacturing operations
Perform QA visual inspection activities associated with clinical and commercial drug product
Participate in regulatory and client audits

Skills and Requirements:

Bachelor's Degree in Life Science field required
4+ years of experience in Pharmaceutical/Biotechnology or Medical Device industry; Minimum of 2 years of experience in Quality Assurance
Excellent written and verbal presentation and communication skills
Strong facilitation skills
Strong problem-solving skills, with the ability to resolve conflict
Ability to effectively present information to management and/or peers
Comfortable working independently in combination with individuals in other departments across the organization

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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