QC Lead Analyst
6 months ago
- Responsible forscheduling/coordination of laboratory activities (routine GMPtesting throughput).
- Demonstrate awareness ofthe scientific principles and method validation for the assayswhich they perform.
- Review GMP assay data andcommunicate findings to manufacturingteams.
- Prioritize and decide appropriate courseof action with minimal supervision.
- Lead labinvestigations
- Coordinate and schedulepreventative maintenance activities with externalvendors
- Perform revision of standard operatingprocedures, act as Process Owner for applicablemethods.
- Train/teach team members on applicableprocedures
- Serve as subject matter expert onvarious methods/topics
- Coach other members ofteam and influences situational adaptability acrossdepartment
- Effectively communicates acrossdepartments on site
- Leads others through highpressure situations, reacts calmly understress
- Support non-routine tests, studies orprojects
- Support the qualification, operationand scheduled maintenance of laboratory equipment, includingautomated and computerized systems and assure they remain in afunctional, validated state. Escalate issues associated withequipment and assays as required.
- Understandand comply with current GMP regulations and quality systems.Promotes a quality mindset in every action, every day by routinelycommunicating concerns, issues and bestpractices.
- Accountable for supporting QC andsite operations, communicating in a positive, professional manner,supporting operational excellence principles and supporting andimplementing management decisions
- Responsiblefor application of GSK safety and environmental guidelines andidentification, escalation and prevention of safety issues. Dutiesmay include minimal handling of hazardous waste from laboratoryactivities to satellite storage areas. Annual training onarea-specific hazardous waste handling is required. This trainingsatisfies annual RCRA training requirement for large quantitygenerators and is part of the site’s RCRA complianceprogram.
- Assist in maintaining area ofresponsibility in a state of inspectionreadiness
- Performs other departmental duties asassigned by management
Whyyou?
BasicQualifications:
Weare looking for professionals with these required skills to achieveour goals:
- Bachelor's Degree in ascientific discipline
- 2+ yearsGMP/pharmaceutical/lab experience
PreferredQualifications:
- Computer skills and knowledge; basicproficiency with Microsoft Officeprograms.
- Demonstrated ability to worksuccessfully both independently and in a teamenvironment
- Good verbal and writtencommunication skills
- Good time managementskills
Pleasevisit GSK US Benefits Summary to learn more about the comprehensivebenefits program GSK offers US employees.
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