- Supervise the disposition team for materials and product manufactured on site in Columbia and product made by contract manufacturing organizations.
- Generate and maintain QA disposition schedule and daily maintenance of inventory levels to ensure coverage meets requirements for each product type.
- Perform and write investigations in relation to product and material NCs and CAPAs.
- Review investigations submitted by the contract manufacturing organization.
- Report Disposition team metrics to management.
- Generate and review document change controls for disposition procedures, product specifications, and material specifications when needed. Communicate with the contract manufacturer on process and document changes.
- Communicate and perform interdepartmental planning activities to ensure that requirements from other departments needed for disposition are being met in a timely manner.
- Execute plans for reducing time consuming processes or practices that delay disposition timelines to increase efficiency.
- Assist with the development of objectives, goals, and plans for individual growth of the disposition team members.
- Perform disposition activities as needed to support team goals and objectives.
- Education:
- B.S .or B.A. degree in Life Sciences or other related scientific field required
- Experience: 5+ years of experience working in quality roles with increasing responsibilities within a regulated biotechnology or pharmaceutical environment (GMP, GTP).
- 2+ years of supervisory experience in a regulated environment
- Auditing experience preferred
- Workplace organization and performance improvement method experience a plus (5S, Lean Six Sigma, etc.)
- Working knowledge of Microsoft Office applications (Word, Excel, PowerPoint)
- Strong working knowledge of Good Manufacturing or Tissue Practices (GMP, GTP).
- Strong written and verbal communication skills internally and externally.
- Demonstrated leadership, organizational, and time management skills.
- Strong Microsoft Office suite and computer application skills. Must be able to navigate Excel and Teams at a minimum to generate scheduling, planning, and metrics data.
- Excellent interpersonal skills internally and externally.
- Demonstrated problem solving and troubleshooting skills in relation to procedures, standards, and policies.
- Physical Demands:
- Must be able to sit for extended periods of time.
- Extended exposure to computer screens.
- Must be able to lift at least 25 lb boxes up to 40 lb boxes.
- Travel Requirements: Domestic - Up to 10%
- Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
- Training: Hands-On, Team-Customized, Mentorship
- Extra Perks: Discounts on fitness clubs, travel and more
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QA Supervisor, Disposition - Columbia, United States - Smith & Nephew
Description
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.The primary purpose of this position is to supervise the team responsible for disposition of materials and product, including product made on-site and product made by contract manufacturing organizations.
This position is critical in ensuring compliance with 21 CFR 1271 and the current Standards for Tissue Banking by the American Association of Tissue Banks.
What will you be doing?We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website ).
Other reasons why you will love it here
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
Work/Life Balance:
PTO, Paid Holidays, Flex Holidays, Paid Community Service Day
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Stay connected and receive alerts for jobs like this by joining our talent community.We're more than just a company - we're a community Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our new website and learn more about our mission, our team, and the opportunities we offer.
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