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Process Coordinator

National Resilience

National Resilience

Alachua, FL, USA
Posted on Friday, February 9, 2024

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 & Responsibilities

Performs tasks in support of the pharmaceutical manufacturing processes in Manufacturing. Specific requirements include authoring and revising of documents, authoring training materials, and The position provides oversight, execution, and approval for transactions in QAD as well as ensuring that OEE performance data is collected as specified for each operating area.

  • Technical writing to include investigations, line assessments, and corrective actions.
  • Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable.
  • Lead training on all document modifications prior to effective date.
  • Investigate manufacturing deviations; close out deviations, CAPAs and/or AFCAs as needed.
  • Author/Approve/Review/Revise/Audit SOPs, Work Instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
  • Coordinate cross-functionally with other departments as required.
  • Alert others (for example: Supervisor/Manager) when problems occur outside of SOPs (Standard Operating Procedures).
  • Attend team meetings to discuss progress, initiatives, and/or other matters.
  • Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on.
  • Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
  • Complete required training.
  • Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation.
  • Gather, organize, and communicate operational information to others.
  • Create training modules and/or resources to ensure that SOPs (Standard Operating Procedures) are covered.
  • Monitor key performance indicators to meet strategic goals.
  • Monitor training of employees to ensure compliance.
  • Read technical publications and manuals and write associated procedures.

Minimum Job Qualifications

  • Experience in documentation in a cGMP environment
  • Experience in a pharmaceutical or cGMP regulated environment.
  • Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
  • Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Preferred Job Qualifications

  • Experience in a production environment
  • High school graduate or Bachelor’s degree with relevant experience
  • Experience working in a LEAN manufacturing environment
  • Knowledge of cGMPs and FDA policies/procedures

Role/Site Specific Requirements

  • This role is primarily a Sedentary role. This can include exerting up to 10 pounds of force to move objects.
  • Visual acuity such as: working with data & figures, viewing computer terminal, and extensive reading.

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.

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 $55,000.00 - $77,500.00 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.