Job Description

Manpower Engineering is partnering with a leader in the Pharmaceutical industry for a Quality Systems Coordinator.

Job Title: Quality Systems Coordinator
Location: Minnetonka, MN
Pay: $30 - $35/hour
Duration: 9 month Contract (potential to go perm)

The Quality Systems Coordinator will support administration of quality system events and GxP records maintenance. They will be responsible for assisting users in transitioning quality events from one phase to the next in a timely manner.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• 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.

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.

Benefits:
Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long-Term Disability Insurance
• Accrued Sick Pay
• 401(k)

Job Tags

Permanent employment, Contract work, Temporary work, Flexible hours,

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