Job Functions:
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Author, revise, review and approve site procedures and policies related to Environmental Monitoring and Sterility as applicable.
- Author quality control EM data trend charts and reports.
- Serve as backup in the absence of microbiology supervisor/management
- Employ aseptic techniques in the performance of testing per USP and Curium Standard Operating Procedures (SOP) and Standard Test Methods (STM) for Sterility, Endotoxin, Bioburden on drug products, intermediates and raw materials.
- Train new employees in microbiological and aseptic techniques and serve as mentor for new and junior employees.
- Perform Growth Promotion testing, Bioburden, and/or sterility testing
- Prepare and analyze Biological Indicators in support of various Validation and Qualification activities.
- Read plates to quantify microbial growth and subculture pure isolates as required.
- General laboratory housekeeping duties.
- Assist with laboratory investigations including OOS, root cause analysis, and implementation of corrective and preventative actions.
- Ensure a safe and quality-minded working environment through conformance with training, general awareness, and compliance to safety/Quality guidelines and SOPs.
Education and Experience:
- Bachelor Degree required (Microbiology, Biology, Cellualar Bigology preferred).
- Five or more years of relevant experience required.
- Previous experience with aseptic process simulations preferred.
- Quality and production experience in a cGMP / FDA regulated facility is required.
#IND-SPG
Estimated Min Rate: $80000.00
Estimated Max Rate: $94000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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