Coordinator II, Quality Systems Contractor
Minneapolis, MN
Full Time
Mid Level
This is a 1099 contract opportunity with no benefits.
POSITION SUMMARY:
Support administration of quality system events and GxP records maintenance. The Coordinator 2, Quality Systems will be responsible for assisting users in transitioning quality events from one phase to the next in a timely manner.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
POSITION SUMMARY:
Support administration of quality system events and GxP records maintenance. The Coordinator 2, Quality Systems will be responsible for assisting users in transitioning quality events from one phase to the next in a timely manner.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Administer and monitor quality event processes, ensuring conformance to standards, and track operational performance.
- Sort and categorize records based on retention schedules, regulatory requirements, and company procedures.
- Organize and maintain physical records to ensure accessibility and traceability.
- Assist in the maintenance and issuance of logbooks.
- Assist in the issuance of manufacturing batch records.
- Supports the complaint handling units in the entry of product complaints.
- Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- High School Diploma or equivalent with minimum of 4 years of experience in the life science or medical device industry.
- An equivalent combination of experience and education may be considered.
- Background in the coordination of quality systems and records management.
- Experience with MasterControl is preferred.
- The candidate will possess broad experience within the Quality function
- Knowledge of GXP, 21CFR, EU GMP, ICH, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance.
- Possessing strong character with self-confidence and integrity necessary to ensure that the best-interests of product recipients and customers are always of first and foremost importance.
- Ability to interface with internal customers at all levels.
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Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.
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