Team Leader, QC
Thermo Fisher Scientific
Team Leader, QC
Job Description
Work ScheduleEnvironmental ConditionsJob DescriptionAs 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.DESCRIPTIONLead 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 operationsPlan and perform quality control testing of reagents and kits using next-generation sequencing and purification methods on the Genexus platformOversee and participate in Out of Specification (OOS) investigations, including root cause analysis and corrective actionsInitiate and manage problem reporting through TrackWise, including deviations, non-conformances, failures, and CAPALead updates to QC testing methods, SOPs, and batch record forms to align with current laboratory practices and continuous improvementsPerform and oversee peer review of QC data packets to ensure data integrity and complianceSupport product development programs, method validation, and process improvementsEnsure the laboratory is well-stocked, resourced, and maintained in a safe, tidy, and efficient conditionFoster a team-first mindset and ensure effective communication across shifts and functionsSupport method validation activities and technical documentation reviewChampion and promote Thermo Fisher's 4 I values – Integrity, Intensity, Innovation, and InvolvementInterface with cross-functional teams and management to drive quality excellence and operational efficiencyEnsure all team members follow good laboratory practices, cGMP requirements, and safe working practicesManage weekend shift operations to support continuous manufacturing needsREQUIREMENTSBachelor's Degree plus 2 years of experience in pharmaceutical/biotech QC laboratory operations1+ years of supervisory experience preferredKnowledge of GMP regulations, ICH guidelines, and pharmacopeia standardsStrong technical proficiency with analytical instrumentation and testing methodsExperience with laboratory information management systems (LIMS) and quality documentationDemonstrated success implementing process improvements and troubleshooting investigationsExcellent project management and organizational skillsStrong interpersonal abilities to lead teams and collaborate across functionsClear written and verbal communication skills, including technical writingProficiency with Microsoft Office suite and statistical analysis toolsAbility to work a fixed weekend scheduleStrong attention to detail and commitment to data integrityExperience managing lab equipment, calibration, and maintenance programsKnowledge of environmental monitoring and contamination controlDemonstrated problem-solving abilities in a structured environmentEnglish proficiency required, additional languages beneficialPREFERRED QUALIFICATIONSPreferred Fields of Study: Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related scientific field1-2 years demonstrated leadership experience managing technical teamsIndustry certifications in GMP/GDP practices beneficialCompensation and BenefitsThe 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 programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt 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 policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Locations
- USA, Maryland, Frederick
Skills Required
- pharmaceutical/biotech QC laboratory operationsintermediate
- GMP regulationsintermediate
- analytical instrumentationintermediate
- laboratory information management systemsintermediate
- Microsoft Office suiteintermediate
- environmental monitoringintermediate
Required Qualifications
- Bachelor's Degree plus 2 years of experience in pharmaceutical/biotech QC laboratory operations (experience, 2 years)
- 1+ years of supervisory experience preferred (experience, 1 years)
- Knowledge of GMP regulations, ICH guidelines, and pharmacopeia standards (experience)
- Strong technical proficiency with analytical instrumentation and testing methods (experience)
- Experience with laboratory information management systems (LIMS) and quality documentation (experience)
- Demonstrated success implementing process improvements and troubleshooting investigations (experience)
- Excellent project management and organizational skills (experience)
- Strong interpersonal abilities to lead teams and collaborate across functions (experience)
- Clear written and verbal communication skills, including technical writing (experience)
- Proficiency with Microsoft Office suite and statistical analysis tools (experience)
- Ability to work a fixed weekend schedule (experience)
- Strong attention to detail and commitment to data integrity (experience)
- Experience managing lab equipment, calibration, and maintenance programs (experience)
- Knowledge of environmental monitoring and contamination control (experience)
- Demonstrated problem-solving abilities in a structured environment (experience)
- English proficiency required, additional languages beneficial (experience)
Preferred Qualifications
- Preferred Fields of Study: Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related scientific field (experience)
- 1-2 years demonstrated leadership experience managing technical teams (experience, 2 years)
- Industry certifications in GMP/GDP practices beneficial (certification)
Responsibilities
- 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
Benefits
- general: 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:
- general: A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- general: Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- general: 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
- general: Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- general: Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
- general: A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- general: Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- general: 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
- general: Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- general: Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
- general: For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
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