Compliance Officer
5 days ago
Compliance Officer
Estimated Salary: $70,000 - $100,000 per year
About UsSaniSure LLC is a global manufacturer of single-use bioprocessing solutions.
We operate a leading platform of vertically integrated critical fluid management technologies and integrated solutions.
Our products are used in the production of biological drugs.
This role is expected to be on-site at our facility.
Job DescriptionThis Compliance Officer position plays a critical role in ensuring our company's compliance with regulatory requirements.
Responsibilities include managing regulatory submissions, conducting audits, and reviewing data and documentation.
The ideal candidate will have experience with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
A Bachelor's degree in Sciences or Engineering is required, along with a minimum of 5 years of experience in quality operations.
A strong understanding of global pharmaceutical and biotechnology product regulations is essential.
The successful candidate will also have excellent interpersonal and customer service skills.
A solid organizational and planning skills are required.
The ability to communicate effectively, verbally and in writing, is crucial.
Proficiency in multiple quality systems including exception management, change control, document control, product release, etc. is desired.
Key Responsibilities:
- Manage regulatory submissions and compliance with applicable national and international regulations.
- Conduct audits and reviews/analyzes data and documentation.
- Host customer audits.
- Perform supplier audits, support supplier audit program.
- Initiate, investigate and complete corrective actions (CA).
- Participate in the MRB meetings.
Benefits:
- Competitive salary range of $70,000 - $100,000 per year.
- Opportunities for professional growth and development.
- Benefits package including health insurance, retirement plan, and paid time off.
About SaniSure LLC:
SaniSure LLC is an equal opportunity employer.
We offer a dynamic and fast-paced work environment.
Join our team and grow your career with us.
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