FSP QA Auditor II

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Thermo Fishers clinical research business is a leading global contract research organization and world leader in serving science. We are passionate deliberate and driven by our mission to enable our customers to make the world healthier safer and cleaner.

Within our Analytical Services team we have a functional service provider solution which is a unique partnership that allows our customers to leverage the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.

• The IQA Specialist supports the Quality Function that they are responsible for within GMP Operations. This includes review and releasing of raw materials and supporting raw material testing. This position will ensure that all products processes or system related quality activities related to raw material inspection and suppliers are in compliance with Corporate and governmental regulations.

• Bachelors Degree in scientific field or equivalent with related experience.

• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2-4 years)

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

• Minimum of 2 years experience in a cGMP-related field (Manufacturing QA QC R&D in pharmaceutical or biologics industry).

• Quality Assurance/Regulatory Affairs/Compliance is preferred

• Responsible for various aspects of quality assurance related to their functional area.

• Review and release raw materials for use in production facility.

• Provide support for raw material testing.

• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR MCA DEA).

• Must have some knowledge of plant and company level procedures.

• Ability to evaluate quality production and support areas for compliance to GMPs. BOPs etc.

• Ability to identify and investigate problems and help to resolve them.

• Support trouble shooting and resolutions of quality compliance issues.

• Assist with drafting raw material specification documents.

Preferred Experience:

Incoming QA - receipt review release of raw materials into manufacturing addition any experience revising raw material specifications.
Supplier QA - experience in management of an Approved Supplier List including supplier change notifications audit assessments and supplier records. Previous knowledge of Viva / OneTrack is a plus.

Below is listed the working environment/requirements for this role:

Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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. As one team of 100000 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 with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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