Full-timeEstimated: $73,000 - $97,000 a year
- Health Insurance
- Disability Insurance
- Retirement Plan
- Dental Insurance
- Life Insurance
- Laboratory Experience
- Quality Systems
- Master's Degree
- Doctoral Degree
- Bachelor's Degree
Full Job Description
The QC Microbiology Manager oversees incubation and analysis of all microbiological samples collected from aseptic production and facility analysis. Samples routinely tested will include media plates, drug product sterility, water bioburden, and other samples as required. The incumbent will be responsible for tracking the receipt and incubation of microbial samples, analysis of endotoxin samples, assurance of sterility method suitability, and identification of objectionable organisms.
Primary duties and responsibilities
- Will act as Site Subject Matter Expert for Microbiology and Aseptic Control
- Reporting to the QC Director for the site, this position is responsible for leading the quality organization areas associated with aseptic quality assurance (microbiology laboratory, environmental monitoring, media fill program, and sterilization services).
- Develop and implement Standard Operating Procedures for new processes such as gram staining, catalase, oxidase, and coagulase tests.
- Train new staff on plate enumeration, microbial morphology, endotoxin testing, and sterility reading.
- This role is responsible for nonconformance reporting, aseptic related GMP investigations, corrective and preventive actions, cGMP document changes, change control, and performance metrics.
- Where appropriate, this position advises the facility staff on changes and their implementation and provides training, tools, and techniques to enable others to achieve compliance.
- Interactions include operations, process engineering, validation, regulatory, FDA, other regulatory agencies and vendor relations.
- Will oversee scheduling incubation and analysis for all aseptic facility and production samples.
- Contribute to the design and plan of validation studies.
- Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects
This description is designed to indicate the general nature and level of work for this position. It is not intended to describe minor duties or other responsibilities that may be periodically assigned.
Experience and Education:
- Education: BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Pharmacy or related science and minimum of 3 years of related experience.
- Experience in a cGMP environment, as described above, with a strong working knowledge of a variety of quality systems
Minimum Skills, knowledge, and abilities
- Proficiency in multi-tasking and must be able to balance multiple priorities.
- Experience in quality assurance within the pharmaceutical and /or biotechnology industry preferred
- Aseptic and sterile manufacturing experience strongly preferred: CAPA and root cause expertise, Internal audit, experience in a QC microbiology laboratory in the pharmaceutical or biotech industry also preferred
- Knowledge of GMPs and their application in aseptic processing (specifically FDA 21 CFR 210, 211, USP 785,797, 800, 61/, 62 and 503b guidance)
- Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
- Strong analytical and problem-solving abilities.
What we offer
- Competitive Wages
- Health Insurance for associates and eligible dependents
- Voluntary Dental Insurance
- Paid time off, including vacations and holidays
- Retirement Benefits
- Life Insurance and LTD Benefits
Job Type: Full-time
- CGMP: 1 year (Preferred)
- Quality Assurance/Quality Control: 1 year (Preferred)