Somerset, NJ, 08873, USA
1 day ago
Senior Regulatory and Compliance Specialist
Adecco is seeking a highly motivated and experienced **Senior Regulatory and Compliance Specialist** to join our client’s team in Somerset, NJ. This role offers competitive compensation ( **$53.00/hour** ) with the potential for full-time employment at the end of the 3 month contract period. As a Senior Regulatory and Compliance Specialist, you will play a critical role in ensuring compliance with global regulations within the pharmaceutical industry. You will be responsible for managing the supplier quality program, conducting audits, and leading inspection preparation activities. **Top reasons to work with Adecco:** + Weekly Pay + Upskilling opportunities through the Adecco Aspire Academy + Dedicated onboarding specialist to guide you from offer to your first day. **Requirements:** + Bachelor’s degree with 5+ years of experience in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems, or related manufacturing function. (Associate degree or High School Diploma with 10+ years of experience will also be considered) + Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities. + Knowledge of US FDA regulatory requirements for solid oral dosage forms preferred. + Experience with audit types and techniques. + TrackWise experience preferred. + ASQ CQA or relevant certification highly preferred. **Description:** + Manage supplier quality program and ensure compliance with Supplier Quality Management deliverables. + Conduct and host customer and internal audits to ensure compliance with cGMPs, corporate, and site standard operating procedures. + Lead inspection preparation activities for US FDA and foreign regulatory authorities. + Lead the internal audit program at the site. + Prepare and submit written responses to audit findings and regulatory observations. + Initiate deviations when necessary and participate in PAI audits. + Participate in supplier and customer quality agreements, as well as global meetings. + Review and approve TrackWise records and revise departmental SOPs as needed. + Adhere to environmental, health, and safety requirements. **Pay Details:** $53.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance
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