Quality Assurance Specialist

Responsibilities:

• Make independent decisions regarding packaging inspections, rework operations, and material disposition in accordance with policies and procedures.
• Prioritize and perform inspections of primary and secondary packaging components and printed materials based on production needs.
• Act as a liaison with suppliers to resolve quality-related issues in a timely manner.
• Provide quality oversight to packaging and manufacturing operations, including review of logbooks and AQL inspection forms.
• Support real-time issue resolution during production and packaging activities.
• Participate in continuous improvement initiatives to enhance inspection processes and efficiency.
• Apply ANSI/ASQ Z1.4 sampling plans, including normal, reduced, and tightened inspection levels.
• Ensure compliance with cGMP requirements related to inspection and quality activities.
• Interpret technical drawings and perform measurements using tools such as calipers and micrometers.
• Review Certificates of Analysis (CoAs) for raw materials, chemicals, and packaging components.
• Collaborate with purchasing and suppliers to resolve documentation discrepancies and shipment issues.
• Maintain accurate and compliant documentation per regulatory and company standards.
• Adhere to safety policies and promote safe work practices.
• Support cross-functional collaboration across teams and departments.

Required Skills And Experience:

• High school diploma or equivalent.
• Knowledge of cGMP regulations related to quality and inspection activities.
• Ability to read and interpret technical drawings and specifications.
• Experience using measurement tools such as calipers and micrometers.
• Strong attention to detail and documentation practices.
• Ability to make independent decisions with minimal supervision.
• Effective communication and teamwork skills.

Preferred Qualifications:

• Associate s degree in a scientific or technical field.
• 2+ years of experience in quality inspection or manufacturing in a GMP-regulated environment.
• Working knowledge of ANSI/ASQ Z1.4 sampling standards and AQL inspection processes.
• Familiarity with inspection levels (normal, reduced, tightened) and switching rules.
• Experience in pharmaceutical, biotechnology, or medical device manufacturing.
• Knowledge of sterile manufacturing or packaging operations.
• Experience reviewing Certificates of Analysis (CoAs).

Soft Skills:

• Strong analytical and problem-solving abilities.
• Detail-oriented with a focus on quality and compliance.
• Good organizational and time management skills.
• Ability to work independently and collaboratively.
• Proactive mindset with continuous improvement focus.