Quality Associate II, Document Control

Quality & Compliance Rochester, Michigan


Description

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

Job Description

 

Job Title

Quality Associate II, Document Control

Company

Par Pharmaceutical

Function

Quality

Location(s)

Various

Department

Quality / Document Control

Direct Reports (list)

n/a

Reports to (title)

Supv. or Mgr., Document Control

Date Submitted

9/9/2016

To be completed by Corporate Compensation:

Job Code

 

Band

 

Date Reviewed

9/9/2016

Benchmark

 

EEO

 

FLSA  (USA only)

Non-exempt

 

Job Summary - a concise overview of the job

The Quality Associate II, Document Control follows the applicable Document Control SOPs and requirements in order to maintain a controlled environment within Document Control. This role, which is customer service oriented, works with various departments to either retrieve completed documents or generate new documents. Works in more complex areas of Document Control including APR documents, the Electronic Document Management System (EDMS), and management of documents during regulatory inspections. Provides guidance to the Document Control staff.   Trains Quality Associate I, Document Control. 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.

Follows all applicable SOPs and Policies and performs document control for all businesses

 

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

Accountability

Responsibilities

% of Time

Compliance

  • Secures and collates documents needed for APR and regulatory submissions
  • Manages document issuance and returns process during regulatory inspections
  • Manages documents as system Admin within EDMS
  • Performs technical review of documents during Doc Control phase of EDMS
  • Tracks the status of documents in Master Control and contacts employees to ensure timely completion of changes
  • Manages distribution and reconciliation of official copy documents
  • Participates in resolving complex issues
  • Issues and maintains controlled document numbering system
  • Issues batch records and associated forms
  • Issues logbooks to departments as needed
  • Maintains batch history log
  • Maintains multi-departmental files of controlled documents
  • Maintains electronic repository of controlled documents
  • Verifies and reconciles controlled documents (logbooks, BPRs, forms, etc.)
  • May enter data from manufacturing into tracking databases
  • Sends and retrieves off-site, archived controlled documents and maintains inventory tracking logs
  • Retrieves documents for issuance and returns during regulatory inspections

50%

Customer Service

  • Retrieves documents for other departments and either makes copies of those documents or scans the documents to the requestor 

40%

Problem Resolution

  • Participates in resolving complex issues

5%

Training

  • Becomes a Qualified Trainer and trains junior/peer Quality Associates

5%

Total

100%

 

Qualifications

Education & Experience

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

  • High school diploma or equivalent with 2 years of relevant experience OR
  • AA/AS degree with 1-2 years of relevant experience
  • Related discipline and certification in assigned area a plus

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.

  • Has knowledge & understanding of cGMPs
  • Understands applicable procedures & documentation SOPs
  • Has knowledge of all current state, federal, and local standards and regulations, e.g., cGMP, OSHA, and DEA
  • Has to acquire knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines

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 ability to apply a high degree of integrity
  • Customer/Stakeholder focused (understand meeting business timelines)
  • Problem-solving and decision-making 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.

  • Walk across plant/warehouse
  • Lift 25+ pounds

 

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 July 2012