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 input
• Perform manufacturing batch record and documentation review with excellent attention to details for completeness and accuracy prior to product release and/or closure
• Perform QA approval of suite and equipment changeover between client processes
• Perform autoclave logbook review and facilitate corrections
• Observe active processing and be available to manufacturing and PE for support
• GEMBA all assigned areas daily and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirements
• Perform quarterly Fit and Finish inspections
• Block/unblock product and materials as needed
• Perform monthly BSC observations
• Attend and participate in daily QA OTF Tier 1 meetings
• Take actions to develop one’s own knowledge and skills
• Perform all training requirements in a timely manner
• Support QAD with Issue Print and Emergency Non-routine label printing on weekends and during off-shifts
• Provide training, coaching, and mentorship to new and/or less experienced team members
• Qualify new team members to perform tasks that require QSME training
• Act as team leader in absence of supervisor
• Effectively manage team’s workload and delegate in absence of supervisor
• Lead team meetings as needed
• Write and review deviations in Trackwise as required
• Author and review procedures in eDMS as required
• Write and implement CAPA’s as needed
• Perform investigation interviews as required
• Participate in interview process as necessary
• Individuals 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 required
• Bachelor’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 required
• Experience in cGMP or other highly regulated industry required
• Two years of experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is highly preferred
• Cleanroom 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 practices
• Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
• Tech transfer experience is a plus
• Experience 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 skills
• Strong interpersonal skills
• Strong written and oral communication skills
• Strong math skills

• Strong attention to detail
• Strong Microsoft Office skills (especially Word and Excel)
  • Solid time management and organization skills

Abilities

• Understand and carry out instructions
• Effectively multi-task
• Work effectively in a dynamic environment
• Able to work under pressure
• Able to work independently
• Demonstrated ability to lead others
• Able to coordinate workload for junior team members
• Able to understand departmental as well as site priorities
• Ability 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 provided
• Must 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