Microbiologist I

americanregent; Brea (CA); On-site; USD 46,000 - 48,000; Full time

Job summary

American Regent is seeking a quality control professional to perform bioburden, endotoxin, and environmental monitoring in manufacturing environments. You will test raw materials, in-process samples, and finished products while supporting aseptic processes and cGMP documentation.

The ideal candidate holds a BS in Microbiology or a related field, up to 2 years of pharma QC experience, and demonstrates independence, strong organization, and meticulous attention to detail.

Qualifications

• BS in Microbiology or related field; up to 2 years pharma QC experience.
• Ability to work independently and manage multiple tasks.
• Strong attention to detail and documentation.

Responsibilities

• Perform bioburden and endotoxin testing per specs.
• Develop, optimize, and validate microbiological test methods.
• Generate protocols, review data, and write final reports.
• Operate Autoclave and Sterilization-in-Place equipment.
• Support environmental monitoring in cleanrooms Grade C & D.

Skills

Bioburden testing

Endotoxin testing

Microbial enumeration

Gram staining

Aseptic process

Documentation accuracy

Education

Bachelor of Science in Microbiology

Equivalent combination of education and experience

Tools

Autoclave

MS Office

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

• 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.

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.

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/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.p