Job Details
Job Title: Coordinator Product Quality Assurance
Duration: Start ASAP through end of year 2024
Location: Onsite in Sudbury, MA 01776
Hours: Monday through Friday, 8am-4pm OR 9am-5pm
Pay: $24.50/hour
Job Description:
Facilitate and coordinate the sending out of testing samples and ensuring timely receipt of results and disposition of materials. Leading the document control process for Pure programs.
Responsibilities:
- sample submission forms.
- Lot Master in JDE will show which ingredients were received.
- out the ingredient testing and finished product testing tracking spreadsheets with due dates.
- samples that were sent RUSH by request of the Planning Department
- up with the labs to ensure proper turnaround times.
- RUSH testing, call the lab(s) in advance to let them know RUSH samples are coming and get from them the expected due date.
- regular testing, calculate the due date on typical turnaround times.
- day before any urgent test is due, follow up with the lab to ensure there are no unforeseen delays and results are on track.
- out (and save on QC/QA server) test results.
- test results
- test results are OOS, start a non-conformance and evaluate for retest requirements.
- test results are in spec, file with the appropriate ingredient release form (or bulk encapsulation file) until all tests are in and coordinate the release of these materials with the appropriate personnel.
- documents to Veeva system
- the Absence of Quality Inspector, perform daily checks that are performed by the Quality team on the production floor. Assist Quality Inspectors in ensuring the highest quality products by being involved in the quality checks in production (capsule weights, cleanliness checks, weighing room, bottling line checks, etc.)
- Document Control Process
- site Business administrator for Veeva Vault system
- workflows and assure completion of documents under document change process.
- in Quality Inspections or audits as primary facilitator or back room lead.
- data to identify areas for improvement in the quality system.
- in corrective and preventive action process management.
- ongoing compliance with quality and industry regulatory requirements.
- the Absence of Quality Inspector, perform daily checks that are performed by the Quality team on the production floor. Assist Quality Inspectors in ensuring the highest quality products by being involved in the quality checks in production (capsule weights, cleanliness checks, weighing room, bottling line checks, etc.)
- in the collection of samples for testing to go out to labs.
- Quality duties as assigned
Qualifications:
Education: Bachelor s degree, in a science field preferred
Experience:
Entry: 0-7 years in a production facility with a similar senior position.
Senior: 7 years in a production facility with a similar senior position. Ability to perform additional QA tasks (demonstrated through skills assessment and/or cross-training).
Principal: 9 years in a production facility with a similar senior position. Ability to perform additional QA tasks (demonstrated through skills assessment and/or cross-training).
Necessary Skills:
- of the Dietary Supplement industry, or similar GMP regulated industry