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QC Microbiology, Analyst I
9 Technology Dr. Marlboro, MA 01752 US
Job Description
- Perform Quality Control Microbiological testing of Environmental Monitoring (EM) - for viable air, non-viable particulates, surface viable monitoring in manufacturing areas/cleanrooms.
- Perform testing for gram staining/microbial identification, Media growth promotion, endotoxin testing, plate reading, and documentation.
- Support cleanroom qualification, gowning qualification, aseptic process qualification and personnel monitoring for manufacturing activities.
- Receive samples for analysis, ship samples for contract lab testing, enter/review data, and organize data according to cGDP/GMP requirements.
- Revise SOPs/forms, and Initiate incident reports for OOS results -support root cause analysis for EM excursions.
- Assist in EM data review for trending and other technical documentation or projects.
- Perform lab set up, housekeeping/routine cleaning, schedule equipment for preventative maintenance, and organization of laboratory areas in accordance with cGLP/GMP.
Required:
• Bachelor’s Degree in biology, microbiology or related life science with 1-2 years’ relevant GMP/pharma/microbiology laboratory experience
• Ability/Flexibility to work evenings and weekends/holidays is required- to support manufacturing operations
• Good knowledge of Aseptic technique and common microbiological testing
• Knowledge of relevant, compliance and guidance documents, documentation (ALCOA +) and data organization
• Must be able to gown into cleanrooms in support of testing and manufacturing activities
• Detail oriented, willingness to learn and follow instructions
• Interpersonal skills and ability to contribute to the success of a team
Preferred:
• Experience of working in a fast-paced team environment, time management, and meet deadlines.
• Team player with the ability and willingness to support other colleagues in the Quality Control department.
• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
• Organization and completion of assay documentation and entering data into QC database.
• Write, revise and review Standard Operating Procedures and Forms.
• Lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.
• Assist in conducting and documenting laboratory investigations.
• Participates in facility start-up, commissioning, and validation activities.
• Ensures equipment operational readiness and assist with troubleshooting in case of equipment failure.
• Perform other lab duties as required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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