Quality Assurance Laboratory Supervisor II
- Provet Pty Ltd
- Phoenix, Arizona (US) - 2401 W. Grandview Rd
- 6mo ago
- Full-Time
- On-site
...
SUMMARY
Quality Assurance Supervisor responsibility is to ensure company and customer quality standards are being met. They work under the supervision of the quality director and assist with maintaining the quality management system, perform internal audits, monitor quality systems, and create escalation pathways for quality issues. They supervise Quality Assurance Technicians and Analyst. They review and approve validations of analytical methods and help with implementation for testing purposes. 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 USP, ICH, cGMP practices, and ISO/IEC standards and protocols.
DUTIES AND RESPONSIBILITIES – QUALITY ASSURANCE SUPERVISOR
The following tasks are performed; however, other duties may be assigned.
- Creates, reviews, and controls standard operating procedures, analytical test methods, policies, forms, training documents, work instructions, etc.
- Assists Quality Director in ensuring compliance with quality plans, documentation requirements, regulatory 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
- Leads laboratory in responding to customer complaints and formulating corrective actions when needed
- Provides mentorship to quality assurance staff 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
- Development of new Quality Assurance and Laboratory programs (environmental monitoring, training, equipment control and maintenance, etc.)
- Evaulation of analytical methods and stability indicating studies for accuracy and completeness
- Conducts internal laboratory audits
- Performs 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
- Assists development and reporting of laboratory key performance indicators
- Reviews equipment IQ/OQ/PQ protocols and reports
SKILLS AND QUALIFICATIONS
- Attention to detail and good organizational skills
- Communication skills and ability to interact with parties both internally and externally
- Skilled at personnel management and team organization
- Decision-making skills
- Computer Literacy with intermediate understanding of Microsoft Office Suite including Word, Excel, PowerPoint, Outlook and Teams
- Experience with quality systems and document control
- Competent with USP Regulations
- Competent with 21 CFR 210 and 211, 21 CFR 820, 21 CFR 11
- Competent with ICH Q2(R2) and Q10
- Competent with ISO/IEC 17025
- Bachelors 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.
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