Quality Supervisor - Finishing & Packaging (2nd Shift)

Job Description

The Quality Assurance Lead –Finishing & Packaging role at Simtra BioPharma Solutions is a member of the Quality Assurance Leadership Team. This role directly supports second and third shift Quality Assurance Associates and Packaging, ensuring finished products meet required specifications by supervising Associates who provide quality oversight in the packaging areas. This position provides decision making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. The QA Lead creates an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product. They communicate effectively with production team members, multiple levels of management, and other customer support departments.

The responsibilities involve:

• Handling multiple projects and demonstrating effectiveness in task completion and problem-solving.
• Planning and scheduling the work of QA inspectors.
• Interviewing, hiring, coaching, and developing staff.
• Developing and maintaining inspection and Label Control documentation procedures.
• Ensuring product compliance regulations are followed.
• Writing, reviewing, analyzing and revising written Procedures.
• Leading process/product improvement projects.
• Maintaining a high level of expertise in current regulatory requirements.
• Managing change control activities/documentation.
• Tracking and trending Quality data for review and reporting.

Requirements:

• Bachelor's degree required preferably in Engineering, Science or related field.
• 3 years experience in Quality or cGMP Manufacturing / FDA regulated environment required.
• 1-2 years of experience in auditing techniques, interpreting regulations and quality system helpful.
• 1 year of leadership required
• Knowledge of inspection/labeling/packaging equipment and processes preferred
• Good interpersonal/communication/influencing/negation skills.
• Good project management skills
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Strong technical writing skills.
• Strong technical, analytical and problem-solving skills.
• Computer proficiency in Microsoft Word, Excel, and Outlook.

Simtra offers:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Paid Time Off
• Paid Holidays
• Paid Parental Leave
• Education Assistance Program
• Employee Assistance Program
• Workout Facility
• Cafeteria