• QA Operations Manager (Fully Onsite)

    ThermoFisher Scientific (High Point, NC)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

    Job Description

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

     

    Excellent Benefits Package

     

    Review our company’s Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards)

     

    Medical, Dental, & Vision benefits-effective Day 1

     

    Paid Time Off & Holidays

     

    401K Company Match up to 6%

     

    Tuition Reimbursement – eligible after 90 days!

     

    Employee Referral Bonus

     

    Employee Discount Program

     

    Recognition Program

     

    Charitable Gift Matching

     

    Company Paid Parental Leave

     

    Career Advancement Opportunities

    Location Information:

    High Point, NC

     

    Click here for site video: High Point Softgels (https://www.youtube.com/watch?v=B1kzDFF39XU&list=PL5zgBTG9MOk8zMfq4L8qtdGR56MB-mPRV)

    Responsibilities

    + Aide in the release of products by resolving CAPA, Change Management, and deviation/OOS compliance issues.

    + Support the plant during regulatory inspections.

    + Ensure the Quality Management System (QMS) is followed at High Point through SOP operational adherence.

    + Leads and manages the DEA program for the site.

    + Lead cross-functional teams in quality/compliance improvement activities.

    + Serve as the primary technical subject matter expert for troubleshooting, problem-solving, and operational quality assurance.

    + Ability to apply sophisticated technical and organizational problem-solving methodologies.

    + Identify negative quality/compliance trends and determine root causes for correction. Assist in assigning appropriate corrective and preventative actions.

    + Maintain up-to-date knowledge of global regulations and quality standards.

    + Review and approve various operational documentation requiring QA oversight.

    + Drive the implementation and improvement of global and regulatory policies and procedures to meet regulatory and customer expectations.

    + Establish collaborative relationships with operations and support group leaders.

    + Manage and develop Quality Assurance Engineers and Data Review teams.

    Qualifications

    + BS degree with 6-8 years of GMP experience within the pharmaceutical or medical device industries.

    + Proven ability to independently prioritize multiple projects.

    + Excellent communication skills for presenting information to senior management and public groups.

    + Advanced proficiency in statistical analysis and problem-solving tools.

    + Ability to meet DEA security clearance requirements.

     

    We value your experience and perspective, and together we will successfully implement strategies that maintain our competitive edge. Apply your skills and be part of our mission to make the world healthier, cleaner, and safer!

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.