QA Operations Manager - Thermo Fisher Scientific : Job Details

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

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeAs part of the Thermo Fisher Scientific team, youll 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 worlds toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Excellent Benefits PackageReview our companys Total RewardsMedical, Dental, & Vision benefits-effective Day 1Paid Time Off & Holidays401K Company Match up to 6%Tuition Reimbursement eligible after 90 days!Employee Referral BonusEmployee Discount ProgramRecognition ProgramCharitable Gift MatchingCompany Paid Parental LeaveCareer Advancement OpportunitiesLocation Information:High Point, NCClick here for site video: High Point SoftgelsResponsibilities

• 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!

Seniority level

• Seniority levelNot Applicable

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance, Product Management, and Engineering
• IndustriesPharmaceutical Manufacturing and Biotechnology Research

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