3rd Shift Quality Assurance Technician

• Provide oversight of the label area including receipt, approval, issuance, counts, accountability and inventory.
• Perform QA functions to include daily manufacturing cGMP inspection and balance/scale checks; product disposition; preparation of CoA/CoM; preparation, revision and issuance of SOPs; preparation, revision and issuance of packaging instructions/specifications and provide support to internal and external customers in compliance with government regulations and customer requirements.
• Provide support during customer and regulatory audits.
• Provide support to the incoming inspection when necessary.
• Maintain Master Manufacturing Records in accordance with regulatory requirements.
• Conduct quality investigations as directed and prepare findings.
• Provide support to internal and external customers.
• Compile all required reports and documents on the performance of the above duties.
• Serve as back-up to QA incoming inspection when needed.
• Perform or assist with internal audits in compliance with cGMP regulations.
• Combination: sit - 50% stand/walk - 50%.
• Other projects or duties as assigned.

Do you have experience in Technical writing?, Do you have a Bachelor's degree?, * Bachelor degree in Science or related field to meet FDA requirements for sign offs.

• 2+ years of quality experience.
• Knowledge and understanding of quality principles and cGMP compliance in a manufacturing environment.
• Working knowledge of various testing apparatus beneficial.
• Detail oriented and well organized; strong math, writing, and reasoning skills.
• Self-starter with ability to work and think independently.
• Effective communication and interpersonal relationship skills.
• Proficiency in Microsoft 365 (Office-Word and Excel).
• Writing skills with the ability to create procedures, packaging instructions and specifications, cGMP documentation.
• Ability to interact and impact quality on the manufacturing floor and support customer requirements.
• Ability to effectively balance and prioritize multiple tasks, deadlines and interruptions simultaneously.
• Lifting: Up to 40 pounds.
• Pass drug test and background check., * Bachelor's (Preferred)

Experience:

• Quality assurance: 3 years (Required)
• Revisions and inspections: 2 years (Preferred)