• Frederick, Maryland
    12 days ago

    Job Description

    Work Schedule

    Environmental Conditions

    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.

    DESCRIPTION

    Lead the Genexus QC weekend shift team while performing hands-on quality control testing to ensure high standards of product quality and regulatory compliance. As Team Leader, QC, you'll oversee and participate in quality control testing of reagents and kits through various testing methods including next-generation sequencing and purification on the Genexus platform.

    This is an on-site position. The shift will either be five 8-hour days Friday through Tuesday, or four 10-hour days Friday through Monday.

    What you will do:

    • Lead and develop the Genexus QC weekend shift team while maintaining a hands-on role in testing operations
    • Plan and perform quality control testing of reagents and kits using next-generation sequencing and purification methods on the Genexus platform
    • Oversee and participate in Out of Specification (OOS) investigations, including root cause analysis and corrective actions
    • Initiate and manage problem reporting through TrackWise, including deviations, non-conformances, failures, and CAPA
    • Lead updates to QC testing methods, SOPs, and batch record forms to align with current laboratory practices and continuous improvements
    • Perform and oversee peer review of QC data packets to ensure data integrity and compliance
    • Support product development programs, method validation, and process improvements
    • Ensure the laboratory is well-stocked, resourced, and maintained in a safe, tidy, and efficient condition
    • Foster a team-first mindset and ensure effective communication across shifts and functions
    • Support method validation activities and technical documentation review
    • Champion and promote Thermo Fisher's 4 I values – Integrity, Intensity, Innovation, and Involvement
    • Interface with cross-functional teams and management to drive quality excellence and operational efficiency
    • Ensure all team members follow good laboratory practices, cGMP requirements, and safe working practices
    • Manage weekend shift operations to support continuous manufacturing needs

    REQUIREMENTS

    • Bachelor's Degree plus 2 years of experience in pharmaceutical/biotech QC laboratory operations
    • 1+ years of supervisory experience preferred
    • Knowledge of GMP regulations, ICH guidelines, and pharmacopeia standards
    • Strong technical proficiency with analytical instrumentation and testing methods
    • Experience with laboratory information management systems (LIMS) and quality documentation
    • Demonstrated success implementing process improvements and troubleshooting investigations
    • Excellent project management and organizational skills
    • Strong interpersonal abilities to lead teams and collaborate across functions
    • Clear written and verbal communication skills, including technical writing
    • Proficiency with Microsoft Office suite and statistical analysis tools
    • Ability to work a fixed weekend schedule
    • Strong attention to detail and commitment to data integrity
    • Experience managing lab equipment, calibration, and maintenance programs
    • Knowledge of environmental monitoring and contamination control
    • Demonstrated problem-solving abilities in a structured environment
    • English proficiency required, additional languages beneficial

    PREFERRED QUALIFICATIONS

    • Preferred Fields of Study: Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related scientific field
    • 1-2 years demonstrated leadership experience managing technical teams
    • Industry certifications in GMP/GDP practices beneficial

    Compensation and Benefits

    The hourly pay range estimated for this position based in Maryland is $31.73–$42.31.

    This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

    • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

    • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

    • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

    • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

    • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

    For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

    Numbers & Facts

    LocationFrederick, Maryland
    IndustryAll
    Company Size10,000 employees or more
    Websitehttps://corporate.thermofisher.com/en/home.html

    About Company

    Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

    All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

    If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

    Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

    Skills

    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Calibrationunmatched
    • Cancerunmatched
    • Chemistryunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corporate Policiesunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Data Qualityunmatched
    • Dental Insuranceunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Documentation Reviewunmatched
    • English Languageunmatched
    • Environmental Monitoringunmatched
    • Food Safetyunmatched
    • GLP (Good Laboratory Practices)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • ICH Regulationsunmatched
    • Identify Issuesunmatched
    • Incentive Programsunmatched
    • Instrumentationunmatched
    • Interpersonal Skillsunmatched
    • Laboratoryunmatched
    • Laboratory Equipmentunmatched
    • Laboratory Information Management System (LIMS)unmatched
    • Laboratory Managementunmatched
    • Laboratory Operationsunmatched
    • Laboratory Techniquesunmatched
    • Leadershipunmatched
    • Life Insuranceunmatched
    • Manufacturing Operationsunmatched
    • Microsoft Officeunmatched
    • Next Generation Sequencing (NGS)unmatched
    • Operational Supportunmatched
    • Operations Managementunmatched
    • Organizational Skillsunmatched
    • People Managementunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Product Developmentunmatched
    • Product Supportunmatched
    • Project/Program Managementunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Controlunmatched
    • Regulatory Complianceunmatched
    • Root Cause Analysisunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Statisticsunmatched
    • Stock Purchase Plansunmatched
    • Team Lead/Managerunmatched
    • Technical Leadershipunmatched
    • Technical Writingunmatched
    • Testingunmatched
    • Vision Planunmatched
    • Writing Skillsunmatched

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