Quality Compliance Specialist

Location: College Station, TX
Department: Azzur Austin LLC

Job Description

Our client, a leader in the pharmaceutical industry, is looking for a QA Supervisor/ Compliance Specialist. This role will be responsible for the leading the compliance team with the management, metrics, and closure of CAPAs, Change Controls, Deviations, and Events. The Supervisor will handle all associated responsibilities in compliance with the clients quality policies and site SOPs to ensure regulatory compliance. 

Responsibilities:
Leadership
  • Mentors and provides leadership to the QA compliance team to ensure it is complying with local and global quality standards, regulatory requirements and partner commitments.
  • Develop, motivate and lead team towards achieving organizational and individual goals.
  • Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
  • Provide QA leadership and support to the organization in conducting deviation investigations, CAPAs, Change Controls, to be compliant and on-time
  • Deliver metrics for understanding process performance and improvement opportunities

Compliance

  • Ensure self, and team, have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
  • Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC.
  • Utilize investigative techniques to assist deviation owners to determine root causes of deviations and proper corrective and preventative actions.
  • Review and/or approve basic and technical documentation to include, but not limited to
  1. Deviation Reports, Corrective Action/Preventive Action Plans and Change Controls
  2. Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Requirements:
  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review and report writing skills.
  • Ability to set personal performance goals and provide input to departmental objectives.
  • Develop staff to maximize contributions to the team and the company.
  • Ability to multitask and easily prioritize work.
  • Ability to work independently with little supervision.
  • Proficient in Microsoft Excel, Word and PowerPoint.
  • All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
Qualifications: 
  • Master’s degree in a science-related field with 2 years of related experience, with 1 years of supervisory experience: OR
  • Bachelor’s degree in a science-related field with 4 years of related experience, with 1 years of supervisory experience.
  • At least 2 years of cGMP experience.
Preferred Qualifications: 
  • Certified Quality Auditor
  • Degree in Biology, Chemistry or Engineering


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