Quality Assurance Coordinator

3 weeks ago

Sudbury, United States Randstad Life Sciences US Full time

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


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:

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.

Description of principal responsibilities:

- Prepare sample submission forms.

  • The Lot Master in JDE will show which ingredients were received.

- Fill out the ingredient testing and finished product testing tracking spreadsheets with due dates.

  • Indicate samples that were sent RUSH by request of the Planning Department

- Follow up with the labs to ensure proper turnaround times.

  • For RUSH testing, call the lab(s) in advance to let them know RUSH samples are coming and get from them the expected due date.
  • For regular testing, calculate the due date on typical turnaround times.
  • The day before any urgent test is due, follow up with the lab to ensure there are no unforeseen delays and results are on track.

- Print out (and save on QC/QA server) test results.

- Review test results

  • If test results are OOS, start a non-conformance and evaluate for retest requirements.
  • If 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.

- Upload documents to Veeva system

- In 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.)

- Manage Document Control Process

  • Boston site Business administrator for Veeva Vault system
  • Manage workflows and assure completion of documents under document change process.

- Participate in Quality Inspections or audits as primary facilitator or back room lead.

- Analyze data to identify areas for improvement in the quality system.

- Assist in corrective and preventive action process management.

- Assure ongoing compliance with quality and industry regulatory requirements.

- In 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.)

- Participate in the collection of samples for testing to go out to labs.

- Other Quality duties as assigned


Qualifications:

  • Education: Bachelor’s degree, in a science field preferred
  • Experience: 0-7 years in a production facility with a similar senior position, 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)., 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:

  • Knowledge of the Dietary Supplement industry, or similar GMP regulated industry
  • Computer Skills (proficient in Excel)
  • Teamwork
  • Organizational Skills
  • Communication Skills

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