Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Lead QA Technician is a quality assurance professional with substantial prior experience of working within a Quality organization in a highly regulated industry. This individual specializes in deviation prevention by executing QA on-the-floor activities that include but are not limited to in-process batch record review, logbook review, GEMBAs of all manufacturing areas, providing feedback to colleagues, observing active processes, supporting Manufacturing and PE by providing Quality input as needed, and requesting the initiation of deviations as they are identified. All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

What will you do? (Responsibilities)   

Spend the majority of work hours in manufacturing areas when production is on-going to oversee activities from a quality perspective and provide QA-related inputPerform manufacturing batch record and documentation review with excellent attention to details for completeness and accuracy prior to product release and/or closurePerform QA approval of suite and equipment changeover between client processesPerform autoclave logbook review and facilitate correctionsObserve active processing and be available to manufacturing and PE for supportGEMBA all assigned areas daily and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirementsPerform quarterly Fit and Finish inspectionsBlock/unblock product and materials as neededPerform monthly BSC observationsAttend and participate in daily QA OTF Tier 1 meetingsTake actions to develop one’s own knowledge and skillsPerform all training requirements in a timely mannerSupport QAD with Issue Print and Emergency Non-routine label printing on weekends and during off-shiftsProvide training, coaching, and mentorship to new and/or less experienced team membersQualify new team members to perform tasks that require QSME trainingAct as team leader in absence of supervisorEffectively manage team’s workload and delegate in absence of supervisorLead team meetings as neededWrite and review deviations in Trackwise as requiredAuthor and review procedures in eDMS as requiredWrite and implement CAPA’s as neededPerform investigation interviews as requiredParticipate in interview process as necessaryIndividuals in this group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential.

Education and Experience

High school degree and five (5) years of experience working in Quality requiredBachelor’s Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry) or other science related field combined with a minimum of three (3) years of relevant experience requiredExperience in cGMP or other highly regulated industry requiredTwo years of experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is highly preferredCleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements

Knowledge, Skills, Abilities
 

Knowledge

Understanding ‘why’ and not just the ‘how’ of processes and practicesKnowledge of Quality practices and cGMP regulations and other international health authority guidelinesTech transfer experience is a plusExperience with investigational writing software system is a plus (Track Wise) along with root cause analysis tools utilized in deviation investigations

Skills

Analytical, critical thinking, and problem skillsStrong interpersonal skillsStrong written and oral communication skillsStrong math skillsStrong attention to detailStrong Microsoft Office skills (especially Word and Excel)Solid time management and organization skills

Abilities

Understand and carry out instructionsEffectively multi-taskWork effectively in a dynamic environmentAble to work under pressureAble to work independentlyDemonstrated ability to lead othersAble to coordinate workload for junior team membersAble to understand departmental as well as site prioritiesAbility to collaborate with colleagues at all levels of organization

Physical Requirements / Work Environment Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods. Repetitive hand motions.Able to gown, wear PPE, and work successfully in a clean room environment
 Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

OTHER

Relocation assistance is NOT providedMust be legally authorized to work in the United States now and in the future, without sponsorship.Must be able to pass a comprehensive background check, which includes a drug screening