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QA Associate III

Company: Sirius Technical Services
Location: Alabaster
Posted on: June 12, 2021

Job Description:

Sirius Technical Services is currently seeking a Quality Assurance Associate III for a long-term contract opportunity in Alabaster, Alabama. Please contact me for more information!
 
  
Essential Duties and Responsibilities 
  • Perform Document Control for Batch Production Records (BPRs), Standard Operating Procedures (SOPs), Raw Material (RM), Avanti Product (AP) specifications and Job Descriptions.
  • Conduct product releases/rejection including review of batch production documents, review of analytical results, and comparison to specifications.
  • May be tasked with the design, development and delivery of high quality and high impact training programs and services that provide functional, GMP and product knowledge for employees to achieve a high level of performance in their jobs. 
  • Implement and follow the Corrective and Preventive Action Program (CAPA) process to ensure effective and timely closure of CAPAs.  
  • Oversight of Facility / Equipment qualification. May be required to help develop and/or review/approve User Requirements Specifications, as well as IQ/OQ/DQ documents.
  • Conduct Annual Product Review.
  • Provide QA input for product shipments including product release, label preparation, review and application, final label review, shipment packaging, and shipment paperwork.
  • Write and revise BPRs, SOPs, RM specs, AP specs and Job Descriptions on a timely basis.
  • Perform annual document reviews (when required by quality systems).
  • Perform internal audits.
  • Conduct raw material qualification and vendor management.
  • Prepare for and assist during customer / FDA audits.
  • Review / Approve Out-of-Specification (OOS) documentation.
  • Perform Change Control (review and approval of Deviations and Change Requests).
  • Perform process / method validation program (including design and review of validation efforts).
  • May maintain or assist in the maintenance of calibration and maintenance database for equipment to ensure that equipment and instruments are fit for use.
  • Keep personal training up-to-date using Quality Management tools provided. 
  • Follow all written policies delivered by Management and/or Regulatory Affairs (Standard Operating Procedures, Chemical Hygiene Plan, Emergency Contingency Plan, training memoranda, policy memoranda, Material Safety Data Sheets, Specification Records, etc.).  
  • Generate quality metrics using specific systems/applications by obtaining raw data, developing quality monitoring database and creating appropriate level reports using MS Excel (pivot tables, charts, graphs, etc.) or other software (MasterControl).
  • Perform or participate in investigations using various tools such as root cause analysis, Failure Mode and Effects Analysis, etc.
  • Assess causes systemically, looking beyond the obvious to determine why people, processes and/or systems are not meeting quality standards. 
  • Analyze resulting quality metrics and assess trends.
  • Work with supervisors of departments to ensure consistency and close gaps in coaching and training.
  • Provide ongoing analysis of data resulting from the quality systems review. Communicate results of analysis to management.
  • Assist GMP work areas in developing, implementing, and maintaining On-the-Job Training (OJT) programs.
  • QA Associate III personnel are expected to assist in the development of junior colleagues and, as assigned by QA Management, take leadership on special projects and routine activities. 
  • Provide new hire GMP training for employees.
  • Other responsibilities that are outlined in one or more different Job Descriptions may be assigned.                                                     
Education and Experience    
  • Bachelor’s Degree required in the field of natural sciences, engineer or management preferred. 
  • Minimum of 10 plus years’ experience in quality or operations, primarily in a cGMP environment.
  • Pharmaceutical operations experience and/or knowledge required.
  • Good knowledge of FDA regulations.
  • Prior CAPA / Investigation oversight experience preferred. 
  • Experience in collecting, analyzing, and presenting data and recommendations to management.
 
Submit your resume to Amber Greene at amber.greene@siriustechnical.com
 
Sirius Technical Services Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.
 

Keywords: Sirius Technical Services, Birmingham , QA Associate III, Other , Alabaster, Alabama

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