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Lead QA Auditor

National Resilience

National Resilience

Quality Assurance
Alachua, FL, USA
Posted on Friday, December 29, 2023

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary & Role:

The Lead QA Auditor is a site position located in Alachua, FL reporting to the Head of QMS & Compliance. The primary responsibility of this role is to ensure there an effective external audit support process and lead the internal audit program.

The Lead QA Auditor leads primary functions and programs for External (Regulatory and Client) Audits and manages and oversees the internal (self) audit program.

Job Responsibilities:

  • Assess the organization to ensure compliance with applicable standards, regulations and guidance

  • Coordinate action plans and follow-up with auditees to assure prompt and adequate completion of agreed upon actions

  • Review, evaluate and assess documentation to ensure compliance to cGMP, industry standards and other applicable regulations.

  • Cross train in departmental duties to assist in meeting the resource needs of the department as assigned

  • Schedule, plan, conduct and lead internal and external audits, to include creating and communicating audit plans, agendas, and reports

  • Drive investigations, perform root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional subject matter experts

  • Monitor and continuously improve the Quality Systems. Perform focused, for-cause and directed audits as requested and necessary

  • Independently manage a comprehensive internal audit program and act as lead auditor in accordance with a defined audit schedule

  • Act as host to customer, external and third-party audits.

  • Act as lead trainer and Subject Matter Expert for FDA or other government agency audit preparedness

  • Maintain and author documents (SOPs, WIs, Forms, Records) associated with the audit program to include writing, reviewing, training, and revising as needed

  • Assess, evaluate, train, and qualify other auditors within the organization. Maintain records of all auditors to demonstrate qualification

  • Track and trend audit results and provide requested data as needed for management review.

  • Position may require travel both domestically and internationally up to 10% of the time.

All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Minimum Qualifications:

  • Knowledge of biologics global regulatory requirements (FDA, EMA, PMDA, Health Canada, etc.)

  • Demonstrated experience in hosting audits and leading audits

  • Excellent communication, organization and customer service skills

Preferred Qualifications:

  • Bachelor’s degree or higher in a science or technical field

  • Significant experience in biologics or pharmaceutical QA with strong QA auditing experience

  • ASQ Certified Quality Auditor or similar

Physical Requirements:

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

  • Climbing

  • Balancing

  • Fingering

  • Stooping

  • Kneeling

  • Repetitive motion

  • Crouching

  • 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:

  • Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.

  • Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.

  • Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.

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

  • Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.

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 is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

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 base pay hiring range for this position is $100,000.00 - $137,500.00 per year. 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.