Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
GENERAL SUMMARY:
Evaluate non-conformances and assess quality impact, recommend corrective actions and follow up to ensure corrective actions implemented are effective. Provide QA presence in the Facility and Metrology areas by conducting compliance walkthroughs and ensure compliance with FDA and other regulatory agency requirements. Partner with Facility and Metrology personnel to resolve compliance issues and ensure a successful compliance profile. Ensure compliance observations associated with Company Facilities are adequately addressed and completed on schedule. Review standard operating procedures, validation protocols/reports, Work Orders and Job Plans. Interact with FDA and other regulatory agencies, as required. Requires ~10% travel.
Experience and Skills:
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1.A BA/BS degree in the sciences or equivalent experience.
2.Minimum of 4 years experience in the Biopharmaceutical industry including 1-3 years experience in Quality Assurance.
3.Thorough understanding of cGMP regulations for Facilities/Utilities and Metrology applications is required. Prior investigation/CAPA experience required.
4.Is famililar with Biotech manufacturing procedures and processes.
5.Excellent written and oral communication skills and must be computer literate.
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 2 Years
Level of Education: Technical College
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Raritan, NJ
Raritan, New Jersey
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