Your Impact

The role of the QA Technical Process Specialist (QATPS) will support the role out, and maintenance of the Quality Management System (QMS), its quality assurance program and the qualification of related equipment/processes. The QATPS will primarily be responsible for providing QA technical support for the organization, including technical writing of controlled documents (i.e., procedures, training modules, batch records, protocols, etc.) and manufacturing oversight of the QMS. The QATPS will work with Subject Matter Experts (SMEs) to formalize process and controlled documents within a general approved format, through the NTx QMS. The QATPS will utilize technical knowledge of the NTx site equipment and/or processes in order to ensure that they remain in a validated state and adhere to cGMP standards as defined in ICH Q7, as they are applied at NTx, Inc.

Your Responsibilities

This role will be required to maintain the manufacturing QA program as it relates to upstream, real time and downstream manufacturing.

Examples of upstream manufacturing QA support:

• Initial qualification activity for process equipment
• Change control management, review and approval for SOPs batch records and training modules
• Issuance of controlled batch records and lot numbers
• Issuance of enzyme inventory for further processing per a production batch record

Examples of real time manufacturing QA support:

• Support during production of a batch
• Oversight to prevent documentation errors and deviations from procedure
• Routine re-qualification activity

Examples of downstream manufacturing QA support:

• Review of executed production batch records
• Oversight / assistance of the execution of investigations
• Batch release when all specifications are determined to meet acceptance criteria, investigations are closed and records are complete.

 Additional duties may be:

• Support of site internal audits, external client audits and regulatory inspections.
• Review of historical data to identify trends, leading indicators that drive QA related key performance indicators.
• Any other activity at the direction of NTx management, in direct support of the QMS at the site.

Your Experience, Knowledge, and Skills

• BA/BS or Associates Degree, or a combination of education and relevant experience.
• 10+ years of relevant experience in a biopharma or pharmaceutical environment.
• Experience working in a GLP/GMP Quality Control and/or QA environment.
• Experienced in Good Documentation Practices (GDP).
• Work effectively as part of the QA team.
• Comfortable working in a fast-paced setting with shifting priorities.

• Competent in the use of Microsoft Office Suite applications, such as MS Word, MS Excel, PowerPoint, etc.

Working Conditions & Physical Requirements

• The working environment is generally favorable and consists of a laboratory environment.
• Lighting, temperature and noise levels are adequate.
• Personal Protective Equipment is required where stated. This includes a lab coat, hair/beard net, safety glasses, and gloves.
• While performing the duties of this job, the employee is frequently required to sit, stand and walk to the different lab areas.
• The employee is occasionally required to lift and/or move materials or equipment up to 25 lbs.
• Frequent use of hands to manipulate, handle or touch objects, tools or controls.
• Specific vision abilities required by this job include vision, color vision, depth perception, and ability to adjust focus.
• Employee may be exposed to moving mechanical parts, fumes or airborne particles and chemicals.

Travel could be up to 30%, this will include international sites as well.

This position is located in Rio Rancho, NM.

At Nature’s Toolbox, we are a small team of great minds with an even larger vision. Join us today and contribute to change how lifesaving therapeutics are manufactured today.

Apply today! www.ntxbio.com/careers/

Nature’s Toolbox Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

NTx is not accepting unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to NTx, including unsolicited resumes sent to a NTx mailing address, email address, directly to NTx employees, or to NTx's resume database will be considered NTx property. NTx will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. NTx will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.