Quality Assurance Manager

Location: Dallas,, $70K plus
Date Posted: 06-30-2015
JOB DESCRIPTION
 
Quality Assurance Manager
 
Full time, salaried, exempt position working in Quality Management Department. Will report to Executive Director of Quality and General Manager.
 
GENERAL DESCRIPTION: The Quality Manager is responsible for all quality activities required for compliance to Company’s quality management system and compliance with applicable cGMP regulations. 
 
DUTIES/RESPONSIBILITIES/FUNCTIONS:
  • Daily oversight of cGMP in the facility and Quality Assurance.
  • Identify and implement appropriate Quality Assurance/Control policies and procedures
  • Provide technical direction for compliance and continuous improvement of the quality management systems
  • Development and improvement of quality systems and procedures.
  • Investigate and document non-conformance issues.  Assist with the identification of root cause, and implement corrective and preventive actions.
  • Effectively troubleshoot quality issues in a fast paced environment
  • Provide expertise knowledge to resolve issues and implement corrections.
  • Monitor processes to assure cGMP compliance and adherence to company SOPs.
  • Works with Quality/Operations Management to address issues and identify trends that help ensure compliance and fosters the development and implementation of process improvement within the organization
  • Develops and/or writes reports and supports the investigative process.
  • Manages and directs the activities of the Quality Management (QM) staff. Direct Staff is 10-11 people.
  • Develops and evaluates personnel to ensure efficient operation of Quality functions.
  • Provide guidance, training, coaching, and work assignments for QM staff and ensures staff training is up to date.
  • Review and approve Master Manufacturing Records (MMRs) and SOP’s in support of quality and operations.
  • Coordinate interdepartmental activities with QC, Supply Chain, Operations, and Customer Service to meet business requirements.
  • Assists internal quality initiatives and internal audits, as required.
  • Assists, as needed, with FDA or other regulatory inspections.
  • Assure compliance to company and industry standards
  • Manage the site Quality Management System including (but not limited to) assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, and manufacturing area support.
  • Coordinate the ISO conformance audits of Company’s Quality Management System, Environmental Management System, and Health and Safety Management system by serving as the ISO Management Representative.
  • Oversee the Final Review of Batch Records and Release of Finished Product according to Current Standard Operating procedures and GMPs.
  • Assist the Executive Director of Quality with the development and maintenance of spreadsheets and tracking tools for measuring department objectives and other metrics for trending.
  • Work cooperatively with co-workers and supervisors
  • Maintain regular and punctual attendance at work.
  • All other duties as assigned.
 
Other JOB FUNCTIONS:
  • Assist Technical Services Department with product registrations.
  • Assist Production, Compounding, Maintenance, Quality Control, and R&D supervisors and managers with technical matters.
 
QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES:
  • Extensive knowledge of 21 CFR Good Manufacturing Practices, specifically part 111 and/or part 211
  • Knowledge of Quality management tools, such as Pareto and histogram analysis, statistical process control, regression analysis, and statistical sampling methods.
  • Thorough knowledge of audits and auditing procedures.
  • Extensive knowledge of health and environmental and safety systems.
  • Knowledge of analytical testing procedures.
  • Detailed knowledge of document and change control procedures.
  • Ability to map processes and write effective Standard Operating Procedures.
  • Proficient in Microsoft Office.
  • Ability to communicate effectively with all levels of personnel and outside parties.
  • Exceptional written and oral communication skills.
 
PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES:
  • Stand/remain upright for 3-4 hours at a time to perform audits.
  • Stand/remain upright for 3-4 hours at a time to perform audits for up to 4 consecutive days
  • Sit up to 4 hours at a time to process paperwork or research regulations.
  • Use keyboard and computer.
 
EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:
  • BS degree scientific or technical field from an accredited college.
  • Minimum 7 years’ experience in GMP-regulated industry with experience conducting GMP internal audits.
  • Minimum 5 years experience in managing Quality Management systems activities such as document and change control, quality systems auditing, supplier management, raw material or finished product inspections, and nonconforming or out of specification review processes.
  • Experience with ISO 9001 Quality Systems implementation and management
  • Experience with developing, or assisting with the development, of a HACCP program
  • Previous experience in pharmaceutical manufacturing environment preferred.
  • ASQ certification preferred.
RELOCATION AND BONUS POTENTIAL
 
 
 
 
Thank you for considering this opportunity!
 
 

 
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