Job Description:

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.


The St Louis site is a fast-paced, 24/7 biologic drug substance manufacturing facility with approximately 1k employees. This GMP facility is focused on cell process development to support the clinical phase and commercial manufacturing by producing products to treat a variety of chronic health conditions including cancers and other life-threatening diseases.


This is a non-supervisory role, reporting to the Supervisor of QA Operations at the Thermo Fisher St. Louis site. This position will be expected to work a shift schedule that includes weekend work. Shift will be Wed-Sat, 10pm-8:30am



Discover Impactful Work:
Senior QA Technician is a quality assurance professional with prior experience of working within a Quality organization. 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
Lead team meetings as needed
Review deviations in Trackwise as needed
Review procedures in eDMS as required
Perform investigation interviews as required
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 prior experience working in Quality, or GMP facility required; Bachelor's Degree preferred


• Two years of experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is 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)
Strong 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
Able 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!


Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.


Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


Accessibility/Disability Access
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*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. Apply Now