Quality Assurance Lead - Finishing (3rd Shift)

The role

The Quality Assurance Lead provides oversight and support to 3rd Shift QA Associates and Manufacturing Packaging. This person supervises QA Associates in the Inspection and Packaging complex to ensure finished products meet required specifications and regulatory standards.

What you will do

• Supervise and lead QA Associates in the Inspection and Packaging complex.
• Provide decision making and oversight to ensure compliance to regulatory agency regulations and Simtra Standard Operating Procedures.
• Plan and schedule the work of QA Inspectors for required quality inspections and label control.
• Interview, hire, coach, and develop staff.
• Conduct performance reviews for all direct reports.
• Participate in or lead process/product improvement projects, validations, and development of new methodologies.
• Ensure Inspection and Packaging complex is always in an audit ready state.
• Assist and approve validations, audits, and assessments.
• Author, review, and/or approve deviations, CAPAs, TSSs, Bills of Materials (BOMs), Finishing Specification Sheets (FSS), and Line Records.
• Manage change control activities and track and trend Quality data.

Required qualifications

• Bachelor’s degree and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate’s degree with at least 3 years of Pharmaceutical Quality/Manufacturing or
• Minimum of 2 years in a leadership role.
• Good interpersonal communication skills.
• Working knowledge of FDA Regulations, Application of Good Documentation Practices and Good Manufacturing Practices.
• Strong technical writing skills.
• Strong problem-solving skills.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, ROBAR, etc.)
• Must be able to perform physical tasks which include bending, twisting, kneeling and stooping.
• Must be able to sit and stand for extended periods of time.
• Must wear appropriate personal protective equipment, as applicable.
• Use of hands and fingers to manipulate office equipment is required.

Nice to have

• science discipline (for Bachelor's degree)
• Knowledge of inspection/labeling/packaging equipment and processes

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program

About the company

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.