Quality Systems Specialist (Documentation Control)

Medical Writer

St. Paul, MN, US

Pay Rate Low: 21 | Pay Rate High: 23

• Added - 30/08/2024

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Quality Systems Specialist

A Quality Systems Specialist is needed to join our client's team! They are experts at custom product creation and manufacture, handling every stage of the process from the first idea to large-scale production and innovative product advancement.

Schedule: Monday – Friday 8am – 5pm

Type of Job: Contract to Hire OR Direct Hire

Pay: 21- 23 (DOE)

Duties/Responsibilities

• Follows all Quality procedures and policies ensuring that Quality System requirements are achieved in an ethical manner.

• Maintains current knowledge of applicable regulations and standards associated with the Quality System.

• Maintains current understanding and compliance with applicable process procedures and company policies.

• Meets commitments on time, in full, and with accuracy and attention to detail.

• Supports Quality Team and Management relative to Document Control and Change Management:

• Process documents create/revise to implement Quality System changes

• Utilize document control software to manage controlled procedures (active and archived)

• Ensures that training is appropriately updated and maintained in software system associated with Quality System Training and documentation changes

• Reviews and supports evaluation of all reported material nonconformances (prior to material release) ensuring appropriate segregation, disposition and corrective actions are implemented

• Utilizes ERP system to document, track and trend nonconformance information

Qualifications:

• Communicates both internally and with customers as needed regarding CAR/CAPA status and effectivity

• Ensuring that procedural timeframes are met to ensure timeliness of the process

• Prior experience in a quality systems environment or relevant experience is required

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.