Hybrid 1st & 2nd Shift Quality Assurance Technician - 4/10's bei None

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

80%

Non-Conforming Events

10%

Process Improvement

10%

Compliance

continuous

Safety

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.

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.

• 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.