QA Lead Deviation Investigator

Position Summary & Role

This QA Lead Investigator role is accountable for supporting the quality management system and requirements for Deviations, CAPAs, Change Controls, Lab Investigations, etc. This role serves as the quality approver for minor and major records, author of critical records and assures the QMS and method lifecycle is compliant, well-organized, effective, and phase appropriate. This role is the technical lead within Quality Operations in support of activities of Quality Control, Manufacturing, Engineering, and Supply Chain. This role takes the lead for many of the responsibilities listed below and represents the quality organization and department in client facing activities at a tactical and strategic level. This role reports to the Head of Quality Operations. The position is located at the Alachua site and requires an onsite presence.

Job Responsibilities

• Independently supports as a quality approver in the Quality Management System for Change Controls, Deviations, Lab Investigations, OOSs, CAPAs, and Risk Assessments.
• Works with initiators, investigators, and stakeholders to ensure change controls and investigations are initiated, performed, and closed within the required timelines.
• Reviews CAPA investigation reports to assess the appropriateness of the identified corrective and preventive action(s) and CAPA effectiveness.
• Provides support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits
• Sterile gowning required to perform activities on the manufacturing floor including, but not limited to critical process observations, investigation support and routine GEMBA walks.
• Ensures quality activities are carried out according to regulatory and quality requirements.
• Participate in applicable network communities of practices and share best practices across the network as well as lead and/or support site and network initiatives.
• Client interactions – QMS record and Change Control Notification to Clients, joint working sessions on investigations and technology transfers, and other client facing responsibilities.
• Review & approval of product & process related change controls (includes Supplier Change notifications) and production documentation.

Preferred Experience, Education & Qualifications

• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
• Track record of driving a quality mindset with stakeholder groups and establishing expectations and processes to maintain a standard of quality assurance and compliance.
• Formal training and experience as a trainer, author, and approver for root cause analysis, problem-solving techniques, and technical writing

• Experience with supporting regulatory inspections
• Excellent oral and written communication skills with strong technical writing experience
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
• Data and metric driven
• Knowledge of manufacturing and testing processes for biologics, vaccines, cell or gene therapy products
• Ability to communicate requirements to stakeholders and navigate the site tier structure for escalation of obstacles for resolution
• Continuous improvement mindset
• Proven record leading cross-functional teams in issue resolution and continuous improvement
• Experience with delivering presentations, facilitating, and teaching to diverse audiences
• Desire and interest to leverage new technology and innovative learning techniques
• Formal training and experience as a trainer in root cause analysis, problem-solving techniques, and technical writing
• Knowledge of phase-appropriate quality systems and product lifecycle requirements

Minimum Qualifications

• Bachelor’s degree or higher in Life Sciences discipline
• Minimum of 7 years of pharmaceutical or biopharmaceutical industry experience with 3 years in Quality Control, Quality Systems, or Quality Assurance
• Hands-on experience with the management of Quality System Processes such as Change Control, Deviation, and CAPA is required. In-depth knowledge of Good Manufacturing Practices (CGMP), Quality Management Systems, and applicable industry regulatory requirements
• Experience and knowledge of cGMP and applicable FDA/EMA regulations in the biotechnology / pharmaceutical industry

Physical Requirements: (rows or statements that are not required to perform the duties of the position)

This job requires the employee to perform the following physical activities:

• Climbing
• Balancing
• Fingering
• Stooping
• Kneeling
• Repetitive motion
• Crouching
• Crawling
• Feeling
• Reaching
• Standing
• Grasping
• Walking
• Pushing
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Temperature changes
• Activities occur inside and outside

This job requires exposure to the following:

• Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

This job requires the following visual acuity requirements:

• preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
• determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $85,000.00 - $107,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.