QCQA Supervisor

Work Schedule

Environmental Conditions

Job Description

As 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.

DESCRIPTION:
Guide quality control and batch release initiatives across life science manufacturing operations while supporting a culture of compliance and continuous improvement. Manage quality control and batch release processes in a manufacturing environment to ensure products meet the highest standards. Collaborate with cross-functional teams to identify efficiencies and create robust processes corrective and preventative actions to drive organizational advancement and increase customer service level. Develop team members to achieve operational excellence and career growth.

REQUIREMENTS:
Bachelors degree plus 5 years of experience in pharmaceutical/biopharmaceutical quality assurance or quality control
Preferred Fields of Study: Chemistry Biology Engineering or related scientific field

Comprehensive knowledge of cGMP FDA regulations ISO standards and other relevant regulatory requirements

Demonstrated leadership experience supervising quality teams

Direct people management: scheduling performance management coaching and development of analysts.

Resource planning and workload prioritization to meet turnaround times (TAT) and release timelines.
Continuous improvement mindset (Lean Six Sigma exposure is a plus).

Strong working knowledge of analytical techniques and understanding of method validation transfer and lifecycle management.

Strong expertise in quality systems including deviation management CAPA change control and batch record review

Proficiency in LIMS and electronic quality systems (eQMS) practices.
Demonstrated success in root cause analysis and quality investigations
Excellent project management and organizational skills
Strong analytical and problem-solving abilities
Superior written and verbal communication skills in English
Proficiency with quality management systems and Microsoft Office applications
Experience with statistical analysis and quality metrics reporting
Ability to build collaborative relationships across functions