Proclinical is currently recruiting for a QC Microbiologist with a pharmaceutical company located in Marietta, PA.
- Provide microbiological testing of finished products, incoming materials, environmental monitoring samples, and utility samples. Tests include: Endotoxin, Bioburden, Sterility, Microbial Identification, Biological Indicator testing, and Growth Promotion. Review and Approve Microbiology Data/Results in accordance with established timelines. Troubleshoot processes, methods, and instruments to optimize performance. Provide technical expertise to less experienced staff.
- Adhere to all EHS policies. Promote Safety culture by on-time reporting of incidents, and identification of ZAPS and HAZ IDs.
- Perform cGMP testing of utilities, bulk/finished products, and validation samples utilizing established methods. Examples of test types include: Endotoxin, Bioburden, Sterility, Microbial Identification, Biological Indicator testing, and Growth Promotion.
- Provide accurate results and interpret data in compliance with cGMP's, procedures and all applicable regulations.
- Testing may occur on first and second shifts and may include weekend and/or holiday work
- Review Microbiology within established timelines.
- Ensure all equipment, supplies and reagents are available and in a GMP state to support testing that is right-first-time and on time. Execute reagent, standard qualifications as required.
- Perform data review/logbooks reviews; manage to ensure releases meet SLA timelines.
- Become knowledgeable of Microbiology tests/processes. Evaluate micro tests/processes, and optimize to incorporate company best practices, incorporate efficiency, and address regulatory gaps.
- Participate in investigations and planned remedial actions for atypical events and/or results in order to support the timely resolution of investigations. Author associated documentation.
- Write, update, and review Laboratory Standard Operating Procedures, Analytical Methods, Specifications and other GMP documents. Execute validation protocols and reports and other equipment-related documents.
Skills and Requirements:
- B.S in Microbiology, Biochemistry, or similar scientific discipline.
- Minimum 1 year of experience in a GMP/FDA regulated environment.
- Minimum 1 year of experience in Quality Control environment in a microbiology/chemistry/biochemistry field.
- Prior work experience and/or able to perform some or all of the following: Endotoxin, bioburden, sterility, growth promotion, microbial IDs.
- Versed in GMPs, FDA and other regulatory agency requirements. Ability to interface with regulatory auditors.
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
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.