Quality Assurance Team Lead

Summary

Experienced professional who assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing. Alternatively, conducts internal production/process and manufacturing/packaging quality control audits and risk assessments. Role may be in Manufacturing or Packaging.

Shift: 12 Hour Rotating Day Shift

What you will do:

• Ensures QA Operations personnel are actively engaging on the GMP manufacturing and packaging floor providing support and guidance to personnel, performing Quality activities, and executing documentation review concurrent with GMP Operations.
• Perform document reviews of SOP’s, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures. May also review raw materials, work orders, validation and MSAT reports.
• Independently write SOPs or associated documentation.
• Independently approve SOPs, Master Batch Records, customer audit and regulatory CAPA.
• Ensures that all QA activities are in compliance with company SOPs, cGMP standards and FDA regulations. Responsible of the disposition of raw materials and/or finished products.
• Assess potential impact to product quality for open deviations during lot release.
• Participate in investigations into minor major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality, or purity.
• Make recommendations of changes to processes and programs.
• Lead, train, develops, manages and retains a team of QA Operations personnel.
• Perform additional job-related assignments as requested by management.
• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear.
• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible.
• Stop work where deemed necessary to maintain safety.
• Other tasks as assigned by QA Manager.

What we are looking for:

• High school diploma required or Bachelor’s degree, preferred
• Bachelors + 5 Years of Experience
• 1-2 Years Experience in Leadership
• Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.