Quality Specialist

Job Summary 

The Quality Specialist is responsible for developing and maintaining required regulatory and industry-based quality standards and documentation.  

Duties/Responsibilities 

• Reviews production batch records for accuracy and completeness to approve intermediate products for production and release products for commercial sale.
• Reviews finished goods batch records, reports all deviations in these records, and assures these have been addressed and resolved prior to issuing approval.
• Conducts spot-check inspections/audits of production operations.
• Communicates quality issues to QA Management in a timely manner.
• Inspects customer returns for damage and performs basic investigation and documenting results prior to second level processing. Supports customer complaint investigations as required.
• Calibrates / maintains laboratory equipment.
• Supports / reviews and may approve SOP revisions, validations and other protocols.
• May lead / own QA department specific NC or CAPA and may provide support of the NC and CAPA processes.
• Serves as member of internal audit team and provides support for internal audits as needed.

Education and Experience 

• Associates or Bachelor’s degree in a Biology, Chemistry, Life Sciences, or other related technical field and 1 year of quality experience in a regulated environment (i.e. medical device, aerospace, defense, pharmaceutical, etc.) is strongly preferred.
• Proficiency in MS Office (Word, Excel, Outlook).
• Ability to work either 1st or 2nd shift or weekend (as needed).
• Previous medical device experience preferred.
• Working knowledge of Internet software; Fourth Shift and MRP Inventory/manufacturing software preferred.

Physical Requirements 

• Must be able to lift up to 15 pounds at a time.
• Must be able and willing to work in a fast-paced environment.
• Must be able to use fingers to grasp, move, or assemble very small objects.
• Prolonged periods sitting at a desk and working on a computer.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work requires operation of a computer.