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Position:
Quality Assurance Director

Employer:
Alturas Analytics

Description:

The Quality Assurance Director works with senior staff and TFM to set strategic direction of the QA department and anticipates future QA needs. The position performs analytical-based auditing activities as necessary and implements auditing systems to ensure complance with GLP requirements. The QA Director performs a wide variety of activities to assure compliance with applicable regulatory requirements. This position will be able to apply regulatory interpretation to a wide variety of work situations of increasing difficulty to most work situations, lead and develop training of scientific and new QA staff. Bachelor’s degree or higher in a science related field or equivalent experience is required. SQA RQAP-GLP or ASQ certification is preferred.



Qualifications/Experience:

The Quality Assurance Director responsibilities include:

  • Performs analytical-based auditing activities as necessary and implements auditing systems to ensure compliance with GLP requirements
  • Applies regulatory interpretation to a wide variety of work situations of increasing difficulty
  • Leads and develops training of scientific and new QA staff
  • Supervises activities of QA staff to ensure timely completion of tasks
  • Represents the company through meetings and communications and interfaces with customers and regulatory officials
  • Performs inspections and audits of study-based protocols, plans, in-process activities, data (paper or electronic), test methods, and a variety of reports and issues inspection and audit reports
  • Reports deficiencies and recommends changes for the laboratory to conform to SOP and regulatory standards and to improve efficiency
  • Assists with development and/or reviews SOPs, Technical Procedures, Qualification Plans, and Validation Plans
  • Acts as the host for regulatory agency inspections and client audits and formulates written responses to any findings

Education and Experience Requirements

  • Bachelor’s degree or higher in a science related field or equivalent experience
  • SQA RQAP-GLP or ASQ certification is preferred
  • 10-15 years of quality control or quality assurance and/or regulatory work experience or an advanced educational degree
  • Working knowledge of MS Office suite (emphasis in Word and Excel)
  • Knowledge of bioanalytical laboratory equipment, assays, techniques is preferred
  • Knowledge of Good Documentation Practices is required
  • Knowledge of FDA Good Laboratory Practices (GLPs) and other FDA regulatory guidances (e.g., Bioanalytical Guidance documents) is required
  • Knowledge of MHLW, OECD, ICH and other regulatory guidances preferred
  • Knowledge of ISO9001 and/or investigative methods
  • 3-5 years of supervisory experience
  • An equivalent combination of education and experience or demonstrated ability may qualify the appropriate personnel for this position

Skills and Abilities Requirements

  • High level of attention to detail and organization of records
  • The ability to utilize appropriate mathematical concepts for interpreting scientific data
  • Ability to read protocols, possess good writing and good oral communication skills
  • The ability to apply reasoning skills to deal with a variety of situations and problem solving
  • Skill in customer service
  • Ability to interpret procedures, regulations and guidelines
  • Ability to travel occasionally for professional development
  • Ability to function effectively in stressful situations

Please submit cover letter and resume to be considered. For complete job description and information about our company, please visit our website:

https://alturasanalytics.com/company/careers/



Location: Moscow, Idaho, USA

Contact: Lauren Bowersox; lbowersox@alturasanalytics.com

Post Date: 5/10/2022 11:03:54 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 5/17/2022; Admin Logon
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