Microbiologist I

American Regent, Inc.; Brea (CA); On-site; USD 46,000 - 48,000; Full time

Benefits offered by this job

Healthcare

Life insurance

401k matching

Paid time off

Job summary

American Regent, Inc. is seeking a Quality Control Technician to perform microbiology testing, including bioburden and endotoxin analyses, across raw materials, in-process samples, and finished products.

The role supports environmental monitoring in Grade C & D cleanrooms and requires strict adherence to cGMP procedures. Ideal candidates have a BS in Microbiology and up to 2 years of pharmaceutical QA experience, with strong documentation and teamwork skills.

Qualifications

• Bachelor of Science in Microbiology or related Biological Science required.
• Up to 2 years of related quality control/QA experience in pharma.
• Must read and follow SOPs and cGMP/cGLP requirements.

Responsibilities

• Perform bioburden and endotoxin testing on materials and finished product.
• Conduct environmental monitoring in cleanroom environments.
• Develop, validate, and review microbiology methods and SOPs.
• Assist in testing and data recording to support manufacturing quality.
• Ensure accurate documentation and regulatory compliance.

Skills

Bioburden testing

Endotoxin testing

Environmental monitoring

Gram staining

Data documentation

Education

Bachelor of Science in Microbiology

Tools

Autoclave

Sterilization-in-Place

Vaporized Hydrogen Peroxide

Job description

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. 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. Assist in the development, optimization, and validation of microbiological test methods. Generate protocols, review data, and write final reports. Initiate and revise SOPs, Test Methods, and Forms and other procedures to ensure compliance. Participate in validation testing activities involving aseptic processes. This includes operation of the Autoclave, Sterilization-in-Place, Vaporized Hydrogen Peroxide. Provide support to the manufacturing/operations department through aseptic process simulations, bacterial retention studies, container closure integrity, SIP verifications. Perform TOC, Endotoxin, and Bioburden testing of High Purity water samples per USP requirements. Read Environmental Monitoring plates and perform microbial isolation, colony morphology, along with gram staining of recovered EM organisms. Assist environmental monitoring (non-viable particulates, microbiological air, and microbial surface) in Grade C & D cleanroom environments within Manufacturing area. Strict adherence to procedures and practices according to FDA regulations & strong emphasis on documentation according to cGMP/cGLP requirements. 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. Minimum of Bachelor of Science degree in Microbiology or related Biological Science, or equivalents combination of education and experience. Up to 2 years of relevant industry experience with related quality control and quality assurance in the pharmaceutical industry. Capable of working independently with minimum input from management. Strong organizational and time-management skills with the ability to make structured decisions on a routine basis. Must be proactive, results oriented, and have strong attention to detail. Strong interpersonal skills with the ability to interact with all departments at all levels in a team environment. Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines. Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to work overtime as needed.

Physical Environment and Requirements

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. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Specific vision requirements include color vision. 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.

Salary and Compensation

Expected Hourly Rate: $33.70-$35.00. The hourly rate displayed is the minimum and maximum or hourly rate 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.

Benefits

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.

Diversity and Inclusion

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.

Legal and Rights Information

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/f 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

Accessibility

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 [e-mail].

Company Values

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles.

Company Background

Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.