Safetec of America, Inc. has been a trusted source of infection control, first-aid, and compliance products for over 30 years.

We are a local, family-owned, OTC pharmaceutical manufacturing company with a reputation for retaining employees because we treat them like family.  We are looking for a full-time Quality Assurance Supervisor to join our growing team!

Responsibilities:

• Effectively oversee the daily schedule of Quality Inspector activities to ensure all cGMP and Quality Management programs are successfully carried out in accordance with Safetec procedures and best industry practices
• Effectively lead plant Quality Inspectors to ensure effective and efficient support of daily plant operations and manufacture of finished goods
• Inform and advise Quality and Operation Management in all matters related to safety and quality, including measuring, tracking, and trending, and reporting of progress against key performance indicators
• Lead and support Quality Assurance related deviations in in-process manufacturing, including but not limited to initiation and disposition of further AQL Inspections
• Complete investigations (NCRs, CAPAS, CARs, and Customer Complaints) as required
• Timely review and approval of raw material chemicals and components to support the manufacturing schedule.
• Facilitate New Employee and Annual cGMP Training for permanent and temporary employees
• Support the Quality Assurance team in Batch Production Record (BPR) and Batch Manufacturing Record (BMR) audits and subsequent dispositions
• Support Internal, External, Customer, and Regulatory Audits and associated activities by coordinating the collection, review, delivery, and return of requested documents
• Support Annual Product Reviews by coordinating the collating, reviewing, and approval of supporting information
• Support Document Change Control (DCO) activities to ensure issuance, review, and approval of change requests are completed in accordance with internal procedures
• Support Validation Activities, as needed, to ensure quality-related protocol requirements and activities are completed
• Support continuous process improvements site-wide through collaboration with applicable departments
• Special projects as required, including general support of Quality Systems and Activities

Qualifications:

• 1-2 years of supervisory experience in a cGMP/FDA manufacturing setting, alternatively, 4+ years in a cGMP/FDA manufacturing setting
• Experience handling multiple responsibilities with minimal direction
• Experience auditing batch records in a cGMP/FDA manufacturing setting
• Strong communication skills and can work well with others
• Strong knowledge of MS Word, Excel, and Outlook  
• HS diploma or equivalent required
• Desired:  B.S. in a related discipline such as biology, microbiology, or chemistry