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Compliance Specialist II

Posted Jul 07
Full Time
Florence, South Carolina

Discover Impactful Work!

The Pharma Services Group (PSG) offers pharmaceutical and biotech customers the industry’s most comprehensive portfolio of products and services to support drug research, clinical trials and production, including world class outsourcing capabilities. This position partners with the members in Quality, Operations, and Procurement to provide GMP Compliance expertise to customers, through establishment and maintenance of the site Supplier Quality Management (SQM) program.

A Day in the Life.

  • Serve as Quality contact and lead on resolution of incoming quality issues and provide review and approval, where applicable, to incoming materials.
  • With training, participate in internal and external (vendor) audits per established schedule and procedure.
  • Partner with site (Logistics and Quality Assurance) and network resources to provide oversight of vendor qualification and site-specific supplier quality issues. Identify, design, and implement process and system improvements.
  • Develop solutions to complex issues and Quality initiatives with inter-organizational

impact, following cGMP regulations and company standards. Develop and train personnel and internal customers on relevant business processes.

  • Serve as the Quality representative on cross-functional and multi-site teams, including

the site Materials Review Board (MRB)

  • Lead department and cross-functional initiatives, including maintenance of the

reduced testing program in collaboration with Quality Control

  • Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
  • Serve as a technical subject matter expert (SME) in support of department functions. Participate as a Compliance representative in team meetings. SME on compliance

issues, independently raises compliance issues with the team. Provides input on

issues discussed informing manager of resolution. Communicates issues to manager

as necessary.

  • Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. Review and approve change requests. Collaborate on and author supplier quality procedures.
  • Provide guidance to internal and external customers on best practices for maintaining

a supplier quality program (including self-audit and supplier quality)

  • Provide technical assessment and approval for controlled document change, provide Quality oversight to internal and external customers. Provide input into the design and presentation of departmental performance metrics.
  • Administer, document and maintain the company's Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems and tools, as well as direct actions.
  • Notify Management of potential quality or regulatory issues that may affect product

quality or regulatory compliance. Sign documents for activities as authorized and described by policies, procedures and job descriptions.

  • Perform other duties as required

KEYS TO SUCCESS.

Education:

Prefer BS degree in Chemistry, Biology or related scientific field; with 3+ years related experience. Will consider Associate's Degree (AA/AS) with 5+ years meaningful experience.

Experience:

Prefer 2 years direct experience in regulatory affairs/Quality Assurance, analytical r&D, or quality control

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered

Competencies:

  • Establish work priorities to meet targets and timelines.
  • Manage competing priorities and allocate, adjust, and optimize assigned department resources. Sound knowledge of cGMPs or equivalent regulations
  • Ability to interpret and relate Quality standards for implementation and review
  • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities Ability to communicate clearly and professionally both in writing and verbally
  • Flexibility in problem solving, providing direction and work hours to meet business objectives Knowledge ofGMPs/QSRs and other

relevant compendia. Able to interpret and apply to operations.

  • Manages projects and works with management to obtain resourcing.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, hear or smell. The employee is occasionally required to walk and stoop, or kneel, crouch. The employee must also occasionally lift and/or move up to 5 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions ofthisjob. Reasonable accommodations may be made for persons with disabilities - employee evaluation to determine fitness will be made by company physician(s).

Employee must comply with all applicable safety and security procedures:

Determine appropriate Action beyond guidelines.

Report potentially unsafe conditions.

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is quiet but usual interruption of work is to be expected.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Disclaimer Statement: "The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified."