- 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
- 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
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Microbiology Services Quality Control Specialist I/II - Daly City, United States - Pacific BioLabs
Description
:Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, microbiology. Founded in 1982, PBL is applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech, and medical device clients. If you are up for a challenge, come join our team
PBL has an immediate opening for a Quality Control Specialist I/II in the Microbiology Services department. Responsibilities of the Microbiology Services Quality Control Specialist I/II include design, coordination, and implementation of quality standards in support of regulated testing. The Microbiology Services Quality Control Specialist I/II will perform peer review of microbiology testing data. The successful candidate will be responsible and thorough, with a willingness to apply their skills in a risk-managed approach to help Pacific BioLabs maintain the highest quality standards.
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
The Microbiology Services Quality Control Specialist I/II will review test data as a subject matter expert, investigate deviation and out of specification occurrences, implement corrective actions, SOP revisions, creation and maintenance of On-the-Job Training records (OJTs), Protocols, and trending reports in accordance with Company SOPs and regulatory requirements.
Major Responsibilities of the Microbiology Services Quality Control Specialist I/II include:
EDUCATION/EXPERIENCE
The pay range for this position is $ $77,000 - $84,000 paid on hourly basis excluding overtime. The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.
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.
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