QA Materials Release Technician

QA Materials Release Technician

At Cooper Vision, a division of Cooper Companies, we're driven by a unifying purpose to help people to experience life's beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia.

We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers.

Job Summary:

The QA Materials Release Technician will perform the inspection of Raw Materials that will include, the quarantining, inspection, and determining the disposition of packaging materials, such as blister labels, cartons, leaflets (IFUs) and over labels. This role will also involve contacting suppliers to discuss delivery issues and/or sending NCRs and NCR samples as appropriate, in the QA Materials Supervisor's absence.

• Reviews, Approves, or Rejects new/updated artwork in Vision Pack.
• Confirms the receipt of components and respective paperwork.
• Completes the analysis of required certificates to determine which testing procedures are required.
• Carefully inspects incoming component pallet(s) for damage, verifies count, and collects samples to audit.
• Performs Incoming Inspection of components in accordance with documented test / inspection procedures.
• Records appropriate data of inspection results.
• Assists supporting departments with the removal of nonconforming components by performing inspections to cull out all conforming components from inventory.
• Assists supporting departments with quantifying nonconforming components, segregating them, and having them systematically removed to prevent future use.
• Creates NCR's (non-conformance reports) when applicable.
• Collects, files, and maintains paperwork (supplier shipment documents, approval sheets, etc.).
• Updates SOP's (standard operating procedures) and creates deviations related to the Incoming Inspection process.

Supportive Functions:

• Supports the QA Auditing team with re-audits of non-conforming finished goods.
• Perform audits as directed from management that may include, but not limited to:
• DHR review, product label / package review
• Assist with process audits to verify conformance with established quality standards. This includes advising, working with managers and supervisor as to the possible improvements to conform to standards.
• Fills in, as needed, on day-to-day audit activities.
• Monitors and enforces compliance to conformance to external regulations, as well as Cooper Vision's rigorous quality standards.
• Reports deviations from established procedures or product standards.
• Serves as a resource to the QA Auditors when interpreting quality standards of components.
• Trouble shoots and problem solves as needed.
• Conducts document review of specifications to ensure procedures and product quality have been maintained.
• Assists in process development, performing approved protocols, validations, and qualifications through direction from leadership.
• Assists in internal audits including audits of department's procedures, processes, and training records, to support approved protocols, validations, and qualifications.
• Assists leadership in establishment of product defect criteria.
• Trains or assists in training of new employees; performs audits on trainees to provide feedback to leadership on training progress.
• Continuously challenges the process as part of Cooper Vision's Continuous Improvement culture.
• Serve as support to supervisor/management as necessary regarding performance and processes throughout the department while present, and a backup in the absence of supervisor/management.
• Performs other duties as assigned or required.

General:

• Understands, acknowledges, and follows all Quality requirements, SOP's (standard operating procedures) and WI's (work instructions)
• Understands and follows all company and department policies and safety guidelines.
• Follows GMP's (Good Manufacturing Practices)
• Mee…