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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP)

Location: United States

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in New Haven, CT.

Job Responsibilities:

Compile data and develop analysis to support Quality Management Reviews
Assist in administering Global Quality analytics processes and developing statistical analysis and reporting mechanisms for GXP systems and processes. To include systems to enhance monitoring, trending and signaling as relates to applicable data sources.
Assist in conducting & establishing trending analysis of existing and new Quality System processes
Participate in process for requesting, reviewing and approving new and/or revised metrics and programs.
Provide input and support managing Quality system analysis.
Participate in the implementation of key Continuous Improvement projects across the Quality network.
Assist in implementing and maintaining processes aligned with applicable policies and standards to report on QS performance data, including monitoring of key leading and lagging indicators of QS performance as well as product performance.
Participate across GXP groups, providing support and consultation
Perform other related duties and special projects as required or requested.

Skills and Requirements:

Bachelor's Degree or Higher
4 to 6 years of experience in biopharmaceutical/pharmaceutical or related industry with background in statistics
Experience participating in cross-functional projects
Knowledge of cGMPs, GXPs and Quality Systems required
Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

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.

#LI-BC1

Salary:

Highly Competitive Salary

Location:

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Proclinical is currently recruiting for an Associate Director of GMP/GDP Audit and Inspection Management for a leading biopharmaceutical company located in Boston, MA.

Author Jason Lawrence

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Highly Competitive Salary

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