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Laboratory QA Specialist

PYRAMID Laboratories, Inc. Costa Mesa ,CA
  • Posted: over a month ago
  • $55,000 to $75,000 Yearly
  • Full-Time
  • Benefits: 401k, dental, life_insurance, medical, vision
Job Description

POSITION SUMMARY:

Responsible for QA related projects that vary in scope, complexity and size. Oversee QC laboratory data to ensure compliance with current GMPs.

PRINCIPAL DUTIES:

  • Review laboratory data and audit to ensure accuracy.
  • Maintain QA records (i.e. logbooks, equipment records, specifications, procedures).
  • Review procedures, SOPs, instrument IQ / OQ protocols and reports, method validation and implementation protocols and reports, and other documentation for regulatory compliance.
  • Coordinate responses to internal, customer and regulatory inspection observations.
  • Coordinate and perform internal audits.
  • Monitor inspection trends for impact on laboratory operations.
  • Ensure the proper storage of controlled documentation like archives and back-ups.
  • Maintain documentation, certifications, and training records.
  • Establish, institute and provide new employee orientation for QA related activities.

REQUIREMENTS:

  • Bachelor's Degree in Chemistry, Biology, or Biochemistry and two (2) to five (5) years of experience in the same or closely related cGMP environment.
  • Demonstrated competence in QA related activities through education and experience.
  • Demonstrated ability to work under minimum supervision; exhibit leadership skills to coordinate personnel and projects on various levels.
  • Excellent oral and written communication skills are required.
  • Experience in sterile product manufacturing is a must.
Company Description
PYRAMID Laboratories, Inc. (PYRAMID) is a rapidly growing Contract Aseptic Manufacturer and Analytical Service provider for the pharmaceutical and biotechnology industries.

PYRAMID offers a wide array of services for all phases of drug development, including:

Aseptic Filling
Formulation & Process Development
Lyophilized Product Formulation & Cycle Development
Product Process Validation
Clinical and Commercial Vial & Syringe fill / finish
Clinical and Commercial Lyophilization batches
Labeling & Packaging
Analytical Quality Control Laboratory Services
Analytical Method Development & Validation
API & Drug Product Stability Studies

PYRAMID Laboratories, Inc.

PYRAMID Laboratories, Inc. (PYRAMID) is a rapidly growing Contract Aseptic Manufacturer and Analytical Service provider for the pharmaceutical and biotechnology industries. PYRAMID offers a wide array of services for all phases of drug development, including: Aseptic Filling Formulation & Process Development Lyophilized Product Formulation & Cycle Development Product Process Validation Clinical and Commercial Vial & Syringe fill / finish Clinical and Commercial Lyophilization batches Labeling & Packaging Analytical Quality Control Laboratory Services Analytical Method Development & Validation API & Drug Product Stability Studies

Address

3598 Cadillac Avenue.
Costa Mesa, CA
USA

Website

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