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Microbiology Services Quality Control Specialist
3 months ago
Description:
The Microbiology Services Department provides testing for a variety of customer needs such as Research and Development, Pharmaceutical/Biotech Manufacturing, Medical Device commercialization, and Clinical Trial support. Service categories include method development, method validation, release testing, and stability testing. The purpose of the Microbiology Services department is to provide results which ensure that our clients’ end products will meet the pre-defined standards for safety, identity, strength, purity, and efficacy.
**JOB RESPONSIBILITIES**
Major Responsibilities of the Microbiology Services Quality Control Specialist I/II include:
- Review study documentation for accuracy, clarity, and compliance with protocols, test procedures, Standard Operating Procedures (SOPs), and applicable regulations
- Ensure Analyst’s training was current at the time of testing
- Determine whether equipment was within period of qualification
- Review electronic data and audit trails to ensure results are accurate
- Verify that method was applied properly
- Ensure laboratory records reflect good documentation practices
- Identify deviations from protocols or approved, written procedures, and participate in the investigation process
- Assist management in the investigation and documentation of Out of Specification investigations
- Assist with customer communication on department related items as directed by management
- Review logbooks
**Requirements**:
**EDUCATION/EXPERIENCE**
- Bachelor’s degree in Microbiology or related field preferred
- Quality Assurance certification is a plus
- Previous experience in Quality Assurance, Quality Control, or testing for pharmaceuticals and/or medical devices preferred
- Excellent data review and analysis skills
- Solid organizational skills
- Strong communication skills
- Knowledge of pharmaceutical and/or medical device regulatory requirements expected (GLP, GMP, GCP)
- Familiarity with standards such as ISO 17025, ISO 9001, ISO 13485 is beneficial
Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors.
