Quality Specialist, Systems

Quality & Compliance Chestnut Ridge, New York


Description

Job Description

 

Job Title

Quality Specialist, Systems

Company

Par Pharmaceutical

Function

Quality

Location(s)

Various

Department

Quality Assurance  / Systems

Direct Reports (list)

n/a

Reports to (title)

Various

Date Submitted

9/8/2016

To be completed by Corporate Compensation:

 

Job Summary - a concise overview of the job

The Quality Specialist, Systems will serve as the lead on the shop floor managing investigations/deviations and the review of documentation i.e. raw material release, bulk release, LIMs sample review. Monitors, tracks, and trends Right the First Time (RFT), Non-Conformances, CAPA, and other Quality Systems.   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.

Will partner with the Quality (shop floor and disposition), Manufacturing, Packaging, Engineering and Technical Operations groups for investigation review and metrics generation.

 

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

Accountability

Responsibilities

% of Time

Continuous Improvement

Monitors, tracks, and trends NCR, CAPA, RFT, etc.

40%

Shop Floor

Monitors and tracks RFT and reviews/approves raw material release, bulk release, LIMs sample review, etc.

20%

Compliance

Initiates communication of due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time

15%

Management Review

Assist in the preparation of Materials for Annual Product Reviews

15%

Assists in the preparation of materials for Quality Council and Management Review

10%

Total

100%

 

Qualifications

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.

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.

  • 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

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.

  • 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 Requirements

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.

        Page 1 of 2

Customer Focus - Breakthrough Thinking – Collaboration – Accountability

 

Endo Job Description Template - Revised July 2012