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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.
impact, following cGMP regulations and company standards. Develop and train personnel and internal customers on relevant business processes.
the site Materials Review Board (MRB)
reduced testing program in collaboration with Quality Control
issues, independently raises compliance issues with the team. Provides input on
issues discussed informing manager of resolution. Communicates issues to manager
as necessary.
a supplier quality program (including self-audit and supplier quality)
quality or regulatory compliance. Sign documents for activities as authorized and described by policies, procedures and job descriptions.
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:
relevant compendia. Able to interpret and apply to operations.
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."