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Quality Assurance Analyst

4 months ago

Phoenix, United States Covetrus Full time

Covetrus is dedicated to advancing the world of veterinary medicine and empowering veterinary healthcare teams across the companion, equine, and large-animal health markets. We provide a comprehensive suite of products, software, and services to help drive improved patient health, strong client relationships, and successful financial outcomes for veterinary professionals.

SUMMARY

Staff Quality Assurance Analyst overall responsibility is to ensure company and customer quality standards are being met. They work under the supervision of the quality assurance supervisor and assist with maintaining the quality management system, perform internal audits, monitor quality systems, and communicate issues to laboratory management. Additional responsibilities include: generation, control, and record keeping of SOPs and other documentation; assist with external audits from state boards of pharmacy, certifying institutions, customers, and regulatory bodies; track, review, and assist laboratory management with customer complaints and corrective actions; review data for errors and ensure that all finalized data packets/certificates of analysis (C-of-As) are complete; support laboratory/operations through answering quality and policy (internal/external) questions; and assist Laboratory Services/Operations as assigned. Quality Assurance Analyst must be self-motivated, and customer focused with good problem-solving, decision-making, troubleshooting, judgment, persuasion, critical thinking, and communication skills. Ability to complete projects with little to no supervision, prioritize projects, have advanced interface with customers, and manage a variety of resources. Must be willing to learn and train to gain knowledge of FDA, cGMP practices, and ISO/IEC standards and protocols

RESPONSIBILITIES

  • Creates, reviews, and controls standard operating procedures, standard test procedures, forms, training documents, and work instructions, etc.

  • Assists Quality Assurance Supervisor in ensuring compliance with quality plans, documentation requirements, ISO standards and other regulatory agency requirements * Reviews laboratory data for documentation errors and completeness

  • Provides guidance to laboratory staff for detection and resolution of any issues dealing with quality

  • Supports laboratory in responding to customer complaints and formulating corrective actions when needed

  • Provides mentorship to quality assurance technicians and facilitates continuing education opportunities

  • Provides training on procedures, FDA regulations, cGMP, and quality documents and the development/enhancement of the training program

  • Assists with onboarding orientation activities for new laboratory personnel

  • Identifies cause of quality problems, documents them, and devises solutions and corrections

  • Assists in development of new Quality Assurance and Laboratory programs (environmental monitoring, training, equipment control and maintenance, etc.)

  • Assists with evaluations of analytical methods and stability indicating studies for accuracy and completeness

  • Conducts internal, technical data audits * Assists with contract laboratory audits

  • Assists with vendor qualifications

  • Participates in external audits from state boards of pharmacy, certifying institutions, customers, and regulatory bodies

  • Conducts internal evaluations for compliance with USP, FDA, ICH, ISO, etc. and performs GAP analysis to determine areas of concern or improvement within the laboratory

REQUIREMENTS

  • Computer Literacy with intermediate understanding of Microsoft Office Suite including Word, Excel, PowerPoint, Outlook and Teams

  • Experience with quality systems and document control

  • Understanding or familiarity with 21 CFR 210 and 211, 21 CFR 820, 21 CFR 11

  • Understanding or familiarity with ICH Q2(R2) and Q10

  • Understanding or familiarity with ISO/IEC 17025

  • Bachelors or Associates degree in any Science curriculum. A sufficient combination of education and work experience may be considered.

  • Willingness to learn new concepts and adapt in an environment with constant change

  • High-level of integrity and willingness to adhere to and enforce regulatory guidance, policies, procedures, and regulations

We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:

* 401k savings & company match

* Paid time off

* Paid holidays

* Maternity leave

* Parental leave

* Military leave

* Other leaves of absence

* Health, dental, and vision benefits

* Health savings accounts

* Flexible spending accounts

* Life & disability benefits

* Identity theft protection

* Pet insurance

* Sales Positions are eligible for a Variable Incentive

* Certain positions may include eligibility for a short term incentive plan

Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.