Nature and Scope
To perform quality control duties including, but not limited, testing raw materials, in-process, and finished goods, as well as environmental monitoring of cleanrooms to support manufacturing activities.
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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Perform bioburden and endotoxin testing of raw material, in-process, and final product to verify that material comply to specification limits. Testing includes Microbial Enumeration, Endotoxin, Gram Stain Analysis, and Growth Promotion.
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Coordinate sample submission to third party contract testing facilities.
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Ordering laboratory supplies and maintaining inventory.
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Assist in the development, optimization, and validation of microbiological test methods.
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Generate protocols, review data, and write final reports.
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Initiate and revise SOPs, Test Methods, and Forms and other procedures to ensure compliance.
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Participate in validation testing activities involving aseptic processes. This includes operation of the Autoclave, Sterilization-in-Place, Vaporized Hydrogen Peroxide.
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Provide support to the manufacturing/operations department through aseptic process simulations, bacterial retention studies, container closure integrity, SIP verifications.
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Perform TOC, Endotoxin, and Bioburden testing of High Purity water samples per USP requirements.
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Read Environmental Monitoring plates and perform microbial isolation, colony morphology, along with Gram staining of recovered EM organisms.
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Assist environmental monitoring (non-viable particulates, microbiological air, and microbial surface) in Grade C & D cleanroom environments within Manufacturing area.
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Assist in reviewal of data generated by department technicians.
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Assist management in data analysis and trending reports.
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Training of new hires.
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Strict adherence to procedures and practices according to FDA regulations & strong emphasis on documentation according to cGMP/cGLP requirements.
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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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Minimum of Bachelor of Science degree in Microbiology or related Biological Science, or equivalents combination of education and experience.
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2-4 years of relevant industry experience with related quality control and quality assurance in the pharmaceutical industry.
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Capable of working independently with minimum input from management.
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Strong organizational and time-management skills with the ability to make structured decisions on a routine basis.
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Must be proactive, results oriented, and have strong attention to detail.
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Strong interpersonal skills with the ability to interact with all departments at all levels in a team environment.
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Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
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Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
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Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Physical Environment and Requirements
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Physically able to wear cleanroom/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 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
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Specific vision requirements include color vision.
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Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
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Employee must be able to occasionally lift and/or move up to 25 pounds.
Expected Salary Range:
$79,000-$84,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide
range of other benefits.
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:
- All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
- 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.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected].
