Quality Specialist, Product Release

Quality & Compliance Rochester, Michigan


Description

Description: cid:A1548F0C-58F6-4866-A7F9-03CA2587CEB3

Job Description

 

Job Title

Quality Specialist, Product Release

Company

Par Pharmaceutical

Function

Quality

Location(s)

Various

Department

Quality Assurance / Operations

Direct Reports (list)

n/a

Reports to (title)

Various

Date Submitted

9/8/2016

To be completed by Corporate Compensation:

Job Code

J03199

Band

B

Date Reviewed

9/8/2016

Benchmark

T438-2B

EEO

2

FLSA  (USA only)

Exempt

 

Job Summary - a concise overview of the job

The Quality Specialist, Product Release reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release.  In addition, confirms that all related Quality events such as CAPAs, Change Controls, etc. are closed prior to releasing the product.  Partners with other departments to ensure that errors are addressed and corrected.  Identifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as needed.  Ensures release meets internal requirements and is performed in a timely and accurate manner.  May participate in “on the floor” activities during product manufacturing.

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.

Supports one component of the Generics Business. 

 

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

Accountability

Responsibilities

% of Time

Quality Product Release

  • Reviews, under minimal supervision, all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release
  • Identifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as needed.  Makes recommendations for corrective action to management
  • Confirms that all Quality events (Change Controls, CAPAs, investigations and any other documentation related to the lot to be released) are complete and closed prior to product release
  • Prioritizes reviews based on production and shipment schedules
  • With guidance, reviews and may approve laboratory Certificates of Analysis for accuracy, communicates with the laboratory on COA discrepancies
  • Performs MAPICS transactions to release product
  • Collaborates with Quality and Manufacturing personnel to correct errors and address Non-Conformances in a timely manner
  • Coordinates with production/ warehouse personnel to place material on Quality Hold as needed
  • May participate in “on the floor” Quality activities during product manufacturing.

80%

Metrics Data

  • Provides data for metrics to measure business compliance to goals

20%

Compliance

  • Follows internal processes related to controlled substances
  • Follows procedures to ensure compliance to regulatory 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

  • BA/BS degree in a related discipline with 3+ yearsrelevant experience, including 1 year in Quality Operations

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.

  • Strong understanding and ability to read and interpret SOPs and function within the scope of procedures
  • Knowledge and ability to work with and navigate computer systems such as MAPICs and LIMS

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.

  • Ability to handle and integrate multiple pieces of data to assure correctness
  • Ability to work with cross-functional teams
  • Able to recognize and identify complex errors such as calculation conversions
  • Able to reconcile batch record entries with other documentation
  • Proof-reading skills and ability to identify errors
  • Customer/stakeholder focused, understands impact of daily work to compliance and business
  • Communication skills
  • Strong basic math skills
  • Ability to follow complex processes
  • Attention to detail
  • Strong documentation skills

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

 

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.

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Customer Focus - Breakthrough Thinking – Collaboration – Accountability

 

Endo Job Description Template - Revised June 2012