Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
GENERAL SUMMARY:
Ensure laboratory compliance with FDA and other regulatory agency requirements. Provide QA presence in the laboratory and ensure laboratory compliance with FDA and other regulatory agency requirements. Partner with laboratory management to resolve compliance issues and ensure a successful compliance profile. Partner with manufacturing to resolve compliance issues involving biochemical, chemical and microbiology. Ensure regulatory observations associated with ImClone laboratories are adequately addressed and completed on schedule. Interact with FDA and other regulatory agencies, as required.
Experience and Skills:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1.Provide QA presence in the laboratories through periodic walk throughs, participation in meetings, and through systems review.
2.Identify opportunites for continuous improvement.
3.Provide oversight for the laboratory non-conformance events program (NCE’s) to ensure quality investigations and determination of root cause, CAPA’s, and support for on-time performance.
4.Review and provide QA Evaluations of laboratory non-conformance events. Participate in Cross Functional Teams in investigations of non-conforming events.
5.Review laboratory SOP’s, Trending reports and laboratory methods validation protocols/ reports and equipment qualification protocols/reports.
6.Provide technical assistance for laboratory compliance.
7.Provide technical support to QA Compliance and Manufacturing in areas relating to biochemistry and microbiology.
8.Provide technical support to Purchasing for vendor issues relating to biochemistry and microbiology.
9.Participate in Regulatory Inspections as necessary.
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
BA/BS degree in the sciences
1.Minimum of 1-3 years of Quality Assurance 2.Experience in QA or QC; focus on biologics preferred.
3.Thorough understanding of cGMP regulations for QC Laboratory applications is required.
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 2 Years
Level of Education: BA/BS
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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