SUPERVISOR QA

Summary: This position is a supervisory leadership position within the QA Auditor group leading QA Auditor daily activities.
Essential Duties and Responsibilities:

• This position is responsible for management of manpower within the Q.A Auditor personnel in regards to vacation, PTO, and PAD approval; performance appraisal activities including coaching, scheduling conflicts, and assignments.
• This position works with QA management to effectively evaluate proper inspection and audit techniques, processes, and documentation including tool calibration, process audits, inspection tool acquisitions, and feedback from auditors.

• This position will be required to properly manage their time between responsibilities on the shop floor and responsibility to the management and communication of audit reporting metrics and documentation.

• This position also fulfills any additional requirements as directed by QA management including assistance or leading third party audits.

Supervisory Responsibilities:This position supervisors QA Leads, QA Specialists, QA Analysts, and QA Technicians.
Education Requirements:Bachelor’s degree in related field required.
Experience Requirements:5+ years leadership role in a functional quality position, preferably from an FDA regulated facility. 5+ years of related experience preferred. Lean Manufacturing experience preferred.
Competencies:

• Effective decision-making ability is preferred.
• Knowledge of cGMP audit and FDA regulations gained in a cGMP regulated industry to provide guidance and training of employees.
• Ability to lead or assist in third party audits.
• Ability to audit manufacturing systems and processes in a cGMP manufacturing facility.
• Statistical process control techniques with analytical analysis preferred.
• Ability to create and manage reporting documentation and databases including charts and graphs.
• Ability to create, revise, and audit work instructions and Standard Operating procedures.
• Ability to learn and understand cross-functional department responsibilities to support cooperation with production, sourcing, planning, and compounding departments.
• Moderate computer skills including: SAP; Microsoft Office products (Excel, Outlook, Word, PowerPoint, Access); Use of inspection tools including calipers, scales, go/no go gages, as well as other inspection equipment and tools as needed.
• Ability to train and advise Q.A Auditors as required.
• Ability to communicate effectively with co-workers and management.

Certificates, Licenses, Registrations:Six Sigma Greenbelt and ASQ certifications preferred, but not required.
Travel:Position may require less than 10% travel
Work Environment:Worker exposed to typical office conditions. Exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level.
Physical Demands: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.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.