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:- 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.
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to
Required Experience:
Manager