Senior Compliance and Regulatory Specialist

Somerset, NJ 08873

Posted: 10/07/2024 Employment Type: Contract Division: Life Sciences Job Number: JN -102024-19739 State: New Jersey

Job Description

Senior Compliance and Regulatory Specialist
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: Senior Compliance and Regulatory Specialist
  • Location: Somerset, NJ
  • Industry: Pharmaceutical
  • Hours: MON - FRI - 8AM - 5:00PM
  • Salary: Up to $53/HR. Based on Experience (Paid Weekly - Benefits Available)
  • Employment Type: 3 month contract (Possible direct offer)

Essential Job Functions:
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance and practical application skills. This individual must be a self-starter, results oriented with the ability to receive, compile, analyze, disseminate, and articulate data and its implications at both site and broader program levels. This role has high visibility within the Somerset site and the greater organization as it touches various functional areas including: Supplier Quality, Regulatory Compliance, DEA, and QMS.

Responsibilities

  • Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required.
  • Facilitate and host customer audits at the site to ensure compliance with cGMP s, as well as Corporate and site standard operating procedures.
  • Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations.
  • Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from initiation, preparation, execution through closure.
  • Lead the internal audit program at the site.
  • Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensure responses are completed as committed.
  • Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met.
  • Initiate deviations when site procedures are not followed.
  • Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensuring audit readiness.
  • Participates in the preparation of Supplier and Customer Quality Agreements.
  • Participate in global supplier and regulatory meetings and effectively represent the site.
  • Review and approve TrackWise Records as needed acting as a QA Representative.
  • Review and revise departmental SOPs as required.

Minimum Education and Experience:

  • A bachelor s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function
  • Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function Knowledge:
  • Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required.
  • Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.
  • Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred
  • TrackWise experience is preferred.
  • ASQ CQA or relevant Certification is highly preferred


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About Somerset, NJ

Explore exciting job opportunities in Somerset, New Jersey! Nestled in the heart of the Garden State, Somerset offers a vibrant job market with excellent growth potentials. Known for its picturesque landscapes and charming neighborhoods, Somerset boasts a rich cultural scene with attractions such as the historic Johnson Park, quaint cafes serving up local delicacies like Taylor ham sandwiches, and the prestigious George Street Playhouse for theater enthusiasts. With easy access to New York City and Philadelphia, Somerset provides the perfect blend of suburban tranquility and urban conveniences. Join us in discovering career possibilities in this captivating region!