Compliance Specialist

02 Dec 2024

Vacancy expired!

Compliance Specialist

Location: Milford, MA

Duration: 6-12 Months +

Duties And Responsibilities
  • Drive quality compliance initiatives:
  • Work within a team to cross functionally to perform gap assessments for global procedures, identifying compliance improvements and efficiencies
  • Support procedural and process changes and updates
  • Implement and drive the Compliance Improvement Plan initiative items
  • Help execute the Compliance Improvement Plan initiative
  • Provide Quality and Regulatory support for clients for authority / agency inspections and audits
  • Help with Regulatory Commitments, work cross site with Global Regulatory team to ensure authority deliverables are met to maintain compliance
  • Participate in due diligence visits with clients
  • Provide inspection support for the timely delivery of documents, provide coaching for subject matter experts for inspection readiness, and review information into the inspections rooms for compliance
  • Coordinate and collaborate responses to client audits and regulatory authority inspections with Subject Matter Experts and key stakeholders
  • Interface with regulators and represent the company during regulatory inspections
  • Support the quality systems which include (but is not limited to) the following:
  • Inspection Readiness Activities for current and new health authority (PAI) inspections
  • Ensure compliance with all regulatory standards, systems, procedures and practices including cGMPs and other regulatory requirements as it relates to Quality Assurance activities in the manufacturing facility.

Qualifications
  • BS in science or equivalent; advanced degree preferred but not required.
  • Minimum of 4+ years’ experience in Quality Compliance or related field in a GxP, GMP biotech/ pharmaceutical manufacturing facility a plus
  • Experience in regulatory authorities and excellent working knowledge of GMPs, including interpretation and application of regulations across the product lifecycle
  • Auditing experience & CDMO experience beneficial
  • Solid analytical and problem-solving skills.
  • Must be a team player.
  • Good interpersonal and communication
  • Good project manager skills

  • ID: #23747438
  • State: Massachusetts Milford 01757 Milford USA
  • City: Milford
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2021-12-02
  • Deadline: 2022-01-30
  • Category: Et cetera