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Quality Systems, Contractor

Quality Systems, Contractor

Planet PharmaMinnetonka, MN, US
23 hours ago
Job type
  • Full-time
Job description

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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.

Job Description

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.
  • Environmental Conditions

    Physical Activities : On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate.

    The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

    Travel

    No travel is required for this role.

    Pay ranges between $30-35 / hr based on experience

    The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

    Seniority level

    Seniority level

    Not Applicable

    Employment type

    Employment type

    Full-time

    Job function

    Job function

    Quality Assurance

    Industries

    Staffing and Recruiting

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