Quality Associate III, Operations

Quality Associate III, Operations

The Quality Associate III, Operations is responsible for actively performing "on the floor" Quality activities during product manufacturing, incoming material and finished goods/labeling operations. Quality activities include product/material sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, and process validation and qualification activities. Communicates to multiple departments and supervision to provide timely process and issue updates. The Quality Associate III identifies and escalates issues or problems to appropriate supervision, participates as a team member on cross-functional teams, participates in reviews and structured processes for continuous improvement, trains other Quality Operations personnel, and participates in resolving complex issues. All incumbents are responsible for following applicable Division & Company policies and procedures.

Responsibilities:

• Performs physical inspection of incoming, in-process and finished product samples as assigned and according to the production schedule.
• Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.
• Is competent in all processes (incoming component/labeling inspection, blending/pellet/mixing/cartridge/Xerogel/primary Packaging, Testopel unlabeled bulk product and secondary packaging inspections).
• Labels in Process and finished product materials with appropriate status.
• Performs GMP related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures.
• Performs Environmental Monitoring programs as needed.
• Performs temperature monitoring, as required.
• Inspects QA retains including purging according to retention schedule.
• Performs in process validation and equipment qualification activities as required.
• Performs other duties including resolving complex issues as directed.

Non-Conforming Events:

• Performs and/or participates in non-conformance investigations and helps drive root cause determination.
• Responds to and escalates events identified during production.

Process Improvement:

• Performs internal site audits as a Quality Operations representative.
• Performs and participates in process improvement initiatives and special projects, as a Quality Operations representative.

Qualifications:

Education & Experience:

• High School diploma or equivalent relevant experience.
• 3-4 years' prior pharmaceutical experience in floor operations is preferred.
• College degree in related field is a plus (AAS/AS/BS).

Knowledge:

• Knowledge of Manufacturing documentation and process flow.
• Good understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
• Understanding of Quality Systems and the role within a regulated industry.

Skills & Abilities:

• Able to communicate effectively with other departments, management, and operational personnel.
• Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).
• Ability to learn new skills and monitor performance for adherence to company procedures and policies.
• Detail oriented, able to work independently and work will in a team environment.
• Good proof-reading skills; ability to identify errors.
• Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs).
• Ability to use measuring equipment, i.e. balance, calipers, pipette.
• Ability to use Microsoft Office software (Word, Excel, PowerPoint, Access).
• Good writing skills (grammar, spelling, organization of thought).
• Good follow up skills to ensure task completion.

Physical Requirements:

• Lift and move up to 50lbs.
• Walk across plant/warehouse.
• Wear appropriate gowning as required.
• Ability to read for extended periods of time.
• Must have good vision (with or without correction) and be free of color blindness.

Compliance:

• Performs System Data Integrity Audit Trail for electronic systems reviews as per applicable procedures.
• Performs in-process audits to identify adherence to SOPs and BPR requirements.
• Trains other Quality Operations personnel.
• Actively participates in training events and maintains currency with assigned training requirements.

Safety:

• Follows all procedures to ensure a safe and compliant work environment.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.