Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
GENERAL SUMMARY:
This position is responsible for reviewing and evaluating corrective/preventive actions (CAPA) and the CAPA effectiveness program and communicates CAPA status to cross-functional departments and quality compliance management. Ensure regulatory/customer observations associated with ImClone manufacturing and facilities are adequately addressed and completed on schedule. Create / Revise SOPs related to CAPA, Biological Product Deviation Reports (BPDR) and NCE /CAPA quarterly metric trend reports. Interact with FDA and other regulatory agencies, as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1.Reviewing and evaluating CAPAs associated with non-conformances and regulatory/customer audits. Review CAPAs to determine their effectiveness and identify trends.
2.Develop metrics for NCE and CAPA systems and present to Site Management.
3.Assist with NCE and CAPA quarterly metric trend and summary reports.
4.Actively participate in Cross Functional Teams in investigations of non-conforming events and CAPA implementation.
5.Identify opportunities for continuous improvement.
6.Work with QA Product Disposition to support Annual Product Reviews.
7.Participate in QA Compliance Team Meetings.
8.Assist in building stand alone CAPA system
9.Create / Revise SOPs associated with CAPA systems. Create NCE /CAPA quarterly metric trend reports and assist with implementation of harmonization processes.
10.Interact with FDA and other regulatory agencies, as required.
11.Provide necessary backup to the CAPA Manager, QA Compliance.
Experience and Skills:
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE
1.A BA/BS degree in the sciences or equivalent.
2.Minimum of 3-5 years experience in the Biopharmaceutical industry including at least 1-3 years experience in quality assurance.
3.Thorough understanding of cGMP regulations for Manufacturing applications is required. Prior investigation/CAPA experience required.
4.Minimum of 1-3 years experience with TrackWise systems
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: 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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