Quality Assurance Supervisor

Quality Assurance Supervisor Buffalo, NY Job Details Full-time $60,000 - $70,000 a year 1 day ago Qualifications Quality control corrective actions Microsoft Word Biology Regulatory inspections Manufacturing management Document review (document control) Microsoft Outlook Process optimization Bachelor of Science Regulatory compliance Compliance audits & assessments Corrective and preventive actions (CAPA) GMP Mid-level Microbiology Bachelor's degree in biology High school diploma or GED Schedule management Key Performance Indicators Supervising experience Bachelor's degree Quality control documentation Continuous improvement Team management Staff training Batch records Auditing experience within manufacturing industry Quality inspection Pharmaceutical plant experience Chemistry Overseeing audit functions Quality assurance within manufacturing 1 year Bachelor's degree in microbiology Communication skills Bachelor's degree in chemistry Customer complaint resolution Full Job Description 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