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Quality Assurance Specialist

PCI Synthesis Newburyport, MA
  • Posted: over a month ago
  • Full-Time
  • Benefits: Vision, Medical, Life Insurance, 401k, Dental

Requirements:

· Bachelor of Science in Chemistry, Biochemistry, Industrial Pharmacy or related scientific field, or foreign equivalent degree, or comparable level of technical training through formal education and/or industrial experience.

· 2 - 5 years’ experience in a cGMP quality, regulatory, and/or chemical manufacturing environment, with applied knowledge of GMP principles across quality disciplines, including but not limited to: Change Control; Training; Investigations; CAPA; Supplier Qualification; ICH stability studies; Method and/or Process Validation.

· Advanced demonstrated knowledge and proficiency in at least one of the following aspects of pharmaceutical operations:

o Analytical services, including equipment operation, laboratory data review, and material testing technologies (e.g. HPLC, GC, FTIR, KF, UV, TOC, wet chemistry)

o Manufacturing, including batch processing, equipment maintenance and calibration, batch record review

Duties:

· Proactively perform Quality Assurance function in full compliance with current Good Manufacturing Practices applying regulations ICH Q7 and 21 CFR 211.

· Consistent contribution to daily Quality Assurance operations, including but not limited to the following:

o Product release, including data and batch record review

o Review, editing and approval of controlled quality documentation

o Quality investigations

o Review of analytical method development and validation

o Change control, including documentation, equipment and process changes

o Inspection / internal audits of the facility to ensure real-time GMP compliance

o Supplier Qualification, including external auditing as needed

o Corrective and Preventative Action program

o Customer Complaints

o Training program

· Assist QA management in efforts at continuous improvement of the quality program, including but not limited to the following:

o Advocate for quality compliance throughout the organization

o Periodic review of critical quality systems

o Report quality metrics / trending

· Take a leadership / ownership role in support of one or more critical quality systems, including but not limited to the following:

o Training: develop and perform training opportunities for PCI personnel in critical quality systems, such as LIR, QI and CAPA

o Investigations: serve as lead for systemic quality investigations; mentor PCI personnel in growth of investigational skills

o Process Validation: serve as PCI subject matter expert for validation of manufacturing, analytical or cleaning processes

PCI Synthesis

Address

9 Opportunity Way Newburyport MA 01950
Newburyport, MA
USA

Website

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