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Job type: Permanent

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

Location: United States

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Albany, NY.

Job Responsibilities:

Assist in internal audit programs as required.
Assist with Regulatory and Customer audits as required.
Develop and maintain a thorough understanding of cGMPs and associated regulations Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements.
Track, review and approve training records and related Quality Documents.
Disposition of final intermediates and APIs (includes review of all associated documentation).
Author and review deviations and investigations. Compile data, prepare and review trends. Identify areas of concern and communicate to management.
Author and review change controls.
Review and approve material release specifications, batch records and certificates of analysis.
Author, review and approve SOPs.
Assist in resolving quality problems/concerns with quality control and manufacturing personnel.

Skills and Requirements:

2-5 years of Quality Assurance experience
Associate's Degree required, Bachelor's strongly preferred
QA Auditing Experience is a plus

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

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.

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