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Quality Compliance Associate
90 Digital Drive Novato, CA 94949 US
Job Description
- Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities
- Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
- Interface with other departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessary
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
- Other duties as assigned
- BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
- Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes
- Excellent written, verbal, analytical, and interpersonal skills
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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