Compliance Specialist
A leading global life sciences manufacturer in Ridgefield, NJ is seeking a detail-oriented Compliance Specialist for a long-term contract role. In this critical quality role, you will lead root-cause investigations and author non-conformance reports (NCRs) to support commercial production and environmental monitoring events while upholding strict cGMP standards. location: Ridgefield, New Jersey
job type: Contract
salary: $20 - 25 per hour
work hours: 9 to 5
education: Bachelors responsibilities:
- Investigate, author, and resolve Non-Conformance Reports (NCRs) for production and environmental monitoring deviations.
- Perform root cause analysis using structured problem-solving methodologies to prevent issue recurrence.
- Partner cross-functionally with Quality Assurance, QC, and Manufacturing teams to develop and execute robust Corrective and Preventative Actions (CAPAs).
- Conduct and document Effectiveness Checks (ECs) to assess the impact and success of implemented remediations.
- Analyze quality and deviation data to track trends, identify risks, and present continuous improvement solutions to leadership.
- Ensure all documentation and investigations align with FDA, cGMP, and ISO 9001 regulations.
Required:
- Bachelor's degree with 3-5 years of QA/manufacturing experience, or High School Diploma/GED with 8-10 years of equivalent experience.
- 2+ years of direct, hands-on experience authoring and investigating deviations/NCRs in a regulated manufacturing setting.
- Demonstrated working knowledge of FDA guidelines, cGMP regulations, and ISO 9001 standards.
- Proven background managing CAPAs and Effectiveness Checks (ECs).
- Strong written communication, problem-solving, and Microsoft Office skills.
- Located within a standard commuting range of Ridgefield, NJ.
skills: Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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