Nature and Scope
This position in the Microbiology Laboratory will be primarily responsible for performing, coordinating and tracking the microbiological testing for in-process and finished products as well as monitoring of controlled manufacturing facilities and utility systems.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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Plan daily workload to meet requirements.
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Conduct microbiological testing including Gram stain, microbial identification, LAL, environmental monitoring, growth promotion, microbial limits and water testing.
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Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas.
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Conducts all water samplings throughout manufacturing facility.
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Logging, reading and recording samples and data per cGMP and applicable compliance requirements.
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Calibration, performance verification of small laboratory instruments.
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Perform media preparation, glassware preparation and operate autoclaves.
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Documents findings and report discrepancies from standards.
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Communicate any discrepancies or deviations to management upon discovery.
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Conducts chart readings daily and changing chart weekly.
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Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements.
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Maintain and analyzes data in database and conduct trend analysis.
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Participate in projects identified
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Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
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Bachelor’s degree in Microbiology, Biology, or equivalent Life Science curriculum required.
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One year experience in the pharmaceutical industry, food industry, Cosmetics, medical devices, Laboratory Pathology preferred.
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Strong ability to work independently and as a team.
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Ability to learn clean room technology and use of aseptic technique.
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Organized individual with strong attention to detail.
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Excellent communication skills (oral and Written).
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Working knowledge of MS-Office software and PC Skills Required.
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Good work ethic and highly motivated.
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Ability to work overtime as needed.
Physical Environment and Requirements
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Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
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Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
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Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Employee must be able to occasionally lift and/or move up to 25 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
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- Our recruiting process includes multiple in person and/or video interviews and assessments.
- If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
- We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
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