Job Functions:
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
- Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc.
- Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.
- Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives.
- Generate, execute and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials.
- Maintain current knowledge of US and international regulations regarding Microbiology, Chemistry and cGMP's.
- Provide support for regulatory agency (i.e. FDA, HC, EU, TGA, etc.) on-site audits.
- Bachelor of Science degree in Life Sciences or Engineering required, or equivalent experience.
- Three or more years of relevant experience in a pharmaceutical/medical device manufacturing environment with strong understanding of and exposure to applicable quality systems required.
- Working knowledge of cGMP guidelines and their application in a controlled aseptic environment preferred.
- Must have awareness of quality systems including Change Control, Internal Auditing, Corrective Action Program, Deviation and Complaint investigations, and Document Management.
- Must have experience with statistical tools.
Estimated Min Rate: $52500.00
Estimated Max Rate: $75000.00
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.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
