Summary
Quality Inspector reports into the Quality Inspection team within the broader Quality Operations department. The Inspector will be primarily responsible for ensuring Quality Finished Goods Inspection and/or Quality Raw Materials Inspection support is available to Manufacturing whenever necessary without interrupting Manufacturing operations. The Inspector may also perform general Quality Operations duties.

Essential Duties and Responsibilities
Inspection Team:

• Responsible for the inspection and verification activities in the manufacturing process. Must always adhere to current Good Manufacturing Practices (cGMPs)
• Inspection and release of raw materials, in-process materials and components, and finished goods.
• Verify various manufacturing steps and techniques.
• Tagging and de-tagging of discrepant material.
• Release of packaged product into warehouse.
• Maintenance and disposal of quality retains.
• Control and verification of patient labels.
• Archiving of quality records.

General Quality Duties

• Closely monitors production lines and personnel to verify compliance to specifications and Good Manufacturing Practices (GMP) requirements.
• Conducts final packaging inspections of final product and documents results in appropriate manner.
• Interacts with appropriate departments to ensure product quality issues are resolved prior to final product release.
• Monitors and ensures proper segregation and identification practices during manufacturing or rework processes.
• Must be able to effectively communicate across all departments and levels of management.
• Other duties, as assigned.

Qualifications

• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Ability to manage / supervise a large team of employees.
• Strong analytical and problem-solving skills.
• Strong communication and leadership skills.
• Strong interpersonal, communication, influencing, negotiation skills.
• Strong time / project management skills.

Education and/or Experience • Bachelor’s degree or

• Associates degree with 1-2 years related experience or
• High School diploma with 2-4 years related experience.
• Experience in a pharmaceutical, medical device, bioscience, or other FDA-regulated environment required.
• Must be familiar with cGMP and FDA requirements.
• Knowledge of aseptic techniques helpful.
• Must have strong computer / data skills.

Physical Demands

• Regular attendance is necessary to perform the essential functions of the job.
• Frequent lifting up to 40 lbs; frequent standing/walking.

Working Environment

• Normal office working conditions: computer, phone, files, fax, copier.
• Personal Protective Equipment: As applicable
• Routine work within a manufacturing environment (manufacturing process equipment, utilities, etc.) and a warehouse environment (forklifts, pallet jacks, etc.)
• Required use of standard warehouse/manufacturing equipment and tools for accessing lots in need of inspection (e.g., pallet jacks, safety razors, etc.)
• May be requested to receive training/certification for forklift usage

Job Types: Full-time, Contract

Pay: $24.00 - $26.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Work Location: In person