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