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Position:
Quality Assurance Manager
Employer:
Alturas Analytics
Description:
The Quality Assurance Manager 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 Manager 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 Manager 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
- 5-7 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
- 1-3 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 12:00:00 AM
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