What are the responsibilities and job description for the QA Specialist position at JUNE JACOBS LABS, LLC?
Experience: The ideal applicant should have previous QA experiences in preparing technical documents and checking compliance submissions, manufacturing records, inspection and test data along with the ability to spot errors. Practical experience with document control and QA support of manufacturing.
Department: Quality & Compliance
Primary Job Duties & Responsibilities:
· Author, maintain, and update test method, protocol, policy, instruction, and SOP accordingly.
· Review manufacturing batch records and laboratory testing data
- Support manufacturing and product testing requests and analysis.
- Prepare and maintain equipment/process validation/qualification reports.
· Prepare and maintain change control, OOS, deviation investigation reports
· Maintain quality & compliance related records
· Prepare and maintain Annual Product Review and Mock Recalls
· Prepare and issue product & process conformity certifications (i.e., COA, COM, COC, etc.)
· Issue and maintain R&D notebooks and manufacturing related logbooks
· Interact with 3rd party laboratories in tracking sample submissions and test results
· Assist in regulatory inspections, third-party audits, and customer on-site audits
· Ensure manufacturing and analytical equipment is appropriately maintained and calibrated.
· Participate as an active member of Compliance team ensuring successful establishment and implementation of ISO 9001/ISO 22716 (Cosmetic GMP)
· Develop, deploy, and maintain the controlled documentation and supporting systems.
Skills & Qualifications:
· Good technical writing skills
- High attention to detail and excellent organizational skills are critical
- Must have the ability to prioritize, manage time well, multitask, and troubleshoot
· Ability to work independently with minimal supervision.
- Knowledge of cGMP requirements is a plus.
- Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
- HS Diploma with min. 5 years’ experience in QA/QC (or bachelor’s degree with 2-5 years’ experience)
Salary : $65,000 - $75,000