Quality Specialist, Systems
Job Summary - a concise overview of the job
The Quality Specialist, Systems monitors, tracks, and trends Non-Conformances, CAPA, complaints and other Quality Systems. Assesses the risk level associated with Non-Conformances and escalates the issue to management. Provides metrics to the Quality Systems and Technology Department for the corporate Quality Index. Works with the team in maintaining a collaborative environment.
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.
Manages the Quality Systems at his/or her site as well as metrics, but may also assist other sites with metrics on an as needed basis
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Monitors, tracks, and trends NCR, CAPA, and complaints, etc.
Assesses risk level associated with NCRs, notifies Planning/Scheduling, and escalates to management
Initiates communication due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time
Assists in the preparation of materials for Quality Council and Management Review
Performs and evaluates CAPA effectiveness checks
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Minimum of BA/BS preferably in life sciences plus a minimum of 3+ years’ experience in the pharmaceutical industry OR
§ MS +1 year relevant experience in pharmaceutical industry.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA
§ Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
§ Technical and quality background related to pharmaceuticals
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.
§ Strong communication skills
§ Strong focus on quality and proven ability to apply a high degree of integrity
§ Customer/Stakeholder focused (understand business plans and operating environment)
§ Technical Writing ability
§ Clear problem-solving and decision-making skill
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Walk across plant/warehouse
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.