QA Inspector II - Collaborative Environment

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