JOB DESCRIPTION

St. Louis MO / Pharma Services Group
Our St Louis site is a lively biologic drug manufacturing facility with around 1k employees. The GMP facility focuses on cell process development for clinical and commercial manufacturing.
This is a non-supervisory role, reporting to the Manager of QA Operations at the Thermo Fisher St. Louis site. This position will be encouraged to work a shift schedule that includes weekend work.

EDUCATION AND EXPERIENCE

• Bachelor’s Degree (BA/BS) in Life Sciences or related field + minimum 5 years proven experience.
• 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.
• Experience with investigational writing software system is a plus (Track Wise) along with root cause analysis tools applied in deviation investigations.

SKILLS

• A successful candidate with the required skills for this role will show the ability to think analytically, critically and demonstrate problem solving skills. Other skills include: strong interpersonal skills, strong written and oral communication skills, strong math skills, strong attention to detail and excelling at Microsoft office skills including Word and Excel. A successful candidate also shows 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 the organization.

• Spend the majority of work hours in manufacturing areas when production is on-going to coordinate activities from a quality perspective and provide QA-related input.
• Perform manufacturing batch record and documentation review with excellent attention to detail 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 vital.
• Members of this team need to acquire agreement and collaboration to address issues and uphold quality culture and standards in Operations without direct authority. Using tact and diplomacy is crucial with all customers