Quality Lab Associate I - Bioburden (7pm-7am)
About The Position
The Quality Lab Associate I conducts microbiological analysis of raw materials, solutions, and components according to approved Standard Operating Procedures, accurately and in a timely manner. The role performs bioburden testing on solutions and components, including total plate count and spore testing, and processes water samples collected by environmental monitoring samplers. The associate operates laboratory equipment, completes scheduled cleaning and preparation activities, reviews and logs samples, enters data into LIMS, and maintains laboratory housekeeping and safety using 6S principles. The position also serves as a mentor to Quality Lab Technician positions. Duties may change, and overtime is worked as required.
Requirements
- Bachelor of Science degree in Microbiology, Biology, or a related science.
- Computer literacy and knowledge of Microsoft Office applications, including Word and Excel.
- Attention to detail and strong organizational skills.
- Basic understanding of laboratory instrumentation.
- Good documentation skills and knowledge of Good Documentation Practices (GDPs).
- Ability to manage multiple tasks and priorities in a timely manner.
- Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLP, and USP testing methodologies.
- Ability to communicate effectively with supervisors and peers.
- Experience implementing general microbiology procedures.
Nice To Haves
- Minimum one year of experience in the pharmaceutical or medical device industry is preferred.
- Familiarity with LIMS or an equivalent system and TrackWise.
Responsibilities
- Conduct microbiological analysis on raw materials, solutions, and components following approved Standard Operating Procedures.
- Perform bioburden testing on solutions and components, including total plate count and spore testing.
- Process water samples collected by environmental monitoring samplers.
- Operate laboratory equipment, including laminar flow hoods, autoclaves, and incubators.
- Perform and document scheduled cleaning and preparation activities, including preparing Spor-Klenz, washing and sanitizing equipment and supplies, discarding used supplies, and restocking test materials.
- Review samples received, log samples, and enter data into the LIMS computer database.
- Maintain general housekeeping of the laboratory and test suites.
- Sustain a clean and safe work environment using 6S principles.
- Serve as a mentor to Quality Lab Technician positions.
- Work overtime as required.
Benefits
- Medical, dental, and vision coverage
- 160 hours of paid time off and paid holidays
- 401(k) match
- Employee Stock Purchase Program
- Paid parental leave
- Tuition reimbursement
- Basic life, accident, short-term disability, long-term disability, and business travel accident insurance
- Flexible Spending Accounts
- Educational assistance programs
- Family and medical leaves of absence
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
