Summary

Job Summary - a concise overview of the job

Quality Technician, Operations is responsible for actively participating in “On the Floor” Quality activities during product manufacturing and packaging. Quality activities include product 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. 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. Perform other duties as assigned.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

Quality Technician, Operations is responsible to support the TriRx business.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Floor

Operations

• Performs physical inspection of 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 at least two or more processes (Weighing, Mixing, Packaging, and Batch Transfer, Creams & Ointments Mfg. and Batch Transfer, Packaging, etc.)
• Follows internal processes related to controlled substances
• Performs GMP related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures
• Collects and appropriately labels Packaging retain samples, and submits to the retain storage room
• Supports process validation and qualification activities
• Quarantines water ports as necessary
  
  

80%

Non-Conforming Events

• Responds to and escalates events identified during production
• Participates in investigations as needed
  
  

10%

Process Improvement

• Participates in gap analysis and recommends revisions to SOPs
• Collaborates with Manufacturing and Quality partners to identify and implement improvements
  
  

10%

Compliance

• Performs in-process audits to identify adherence to SOPs and BPR requirements
• Actively participates in training events, and maintains currency with assigned training requirements
  
  

continuous

Safety

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

continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• High school diploma or equivalent plus 3 years of relevant experience
  
  

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Ability to communicate and work with teams
• Attention to detail
• Strong documentation skills
• Ability to read and interpret SOPs and function within the scope of procedures
  
  

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• Is competent in at least two or more processes (Weighing, Mixing, Packaging, and Batch Transfer, Creams & Ointments Mfg. and Batch Transfer, Packaging, etc.)
• Able to communicate effectively with other departments, management and operational personnel
• Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
• Proof-reading skills; ability to identify errors
• Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)
  
  

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Lift 15 to 25 lbs.
• Walk across plant/warehouse
• Wear appropriate gowning as required
• Ability to read for extended periods of time
  
  

5:00am - 3:30pm Monday - Thursday (4/10's) Mandatory Fridays, Often