Quality Assurance Operations Manager - Altavista, VA Plant

Abbott • Altavista, VA

1d • $129,300 - $258,700 • Onsite

About The Position

QA Ops Manager Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Altavista, Va., is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like you’re part of a family that works together to make a difference and help nourish millions of families around the world. The Quality Assurance Operations Manager manages subordinate QA groups within a manufacturing plant with the focus of ensuring the accuracy of quality documentation. Primary responsibilities would include but not limited to new product registrations, change management of existing documentation, batch record review and product release. The position would also set the strategy for their areas of responsibility to ensure the site maintains best practices for quality document control

Requirements

• Bachelor’s Degree in a scientific or technical discipline.
• Minimum 7 years of experience in function or related field.
• 4 years of direct supervisory experience
• Must have demonstrated solid knowledge and experience in discipline.

Responsibilities

• Responsible for the detailed end to end review of all batch documentation to ensure compliance with all policies, procedures and regulations related to the product up to and including CAPA, interventions and environmental monitoring data prior to batch release for commercial distribution.
• Accountable for Batch Release Process Management, which would include identifying all batch non-conformance and initiate appropriate actions for those non-conformances.
• Control release of product to market and coordinate the quarantine of nonconforming finished products.
• Maintenance of batch release, discrepancy and non-conformity metrics and tracking MSP performance with other site departments.
• Review and approval of all change requests to site related documentation and assessment of all Corporate and Divisional policy updates.
• Partner with affected groups to ensure change control is maintained and site training is updated to reflect changes. This would include new product introductions, label copy adherence and product certification.
• Accountable for maintaining the site Documentation system and QA Work Order systems. Ensure that all QA documents meet established Abbott and regulatory standards and that these documents stored in an effective system.
• Identify gaps in Plant Documentation and systems and take necessary actions to correct.
• Responsible for Executive Leadership activities – setting strategy for teams, employee development and effective change management in relation to quality documentation.
• Considered a Subject Matter Expert and key contributor to initiatives.
• Leader and key contributor to initiatives and advancement of the Quality organization.
• Makes decisions and charts course through careful evaluation of risks and benefits with limited information in conjunction with Site QA Director.
• Builds/drives relationships and teamwork within team and across functions with professional demeanor.
• You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees