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Quality Assurance Manager in Ranchos de Taos, NM at Apex Life Sciences

Date Posted: 12/13/2018

Job Snapshot

Job Description

Quality Assurance Manager

Growing manufacturing company in rural New Mexico is looking for an experienced Quality Assurance Manager with excellent cGMP skills. You will join a team that strongly believes protecting the safety and quality of our products to be a core mission. This requires a person who is able to provide leadership and guidance in our manufacturing facility, ensuring compliance with our internal SOPs and current FDA regulations. You will make certain our products meet the highest standards for safety, quality and health and be responsible for the management of the day-to-day quality functions of our overall manufacturing services: preparing and completing action plans; implementing production, productivity, quality and customer service standards; identifying and resolving problems; completing audits; determining system improvements and implementing change.

Job Description and Responsibilities

Lead the Company’s QA efforts to achieve quality metrics consistent with company culture, values and FDA regulations. You will do so by providing direction, mentorship and leadership to all you come across.

Work closely with management, QC, our analytical lab, production and shipping.

Act as liaison for all quality initiatives and quality audits.

Manage all quality and customer complaint issues.

Responsible for compliance and record keeping of all mandated quality checks, testing, production, packaging and sanitation activities.

Responsible for plant compliance concerning good hygiene practices, and cGMP compliance.

Implementation of all Product Safety and Quality Systems and processes; GMP's, GLP's, hold & release, traceability, sanitation and pest control.

Review all product, packaging, and raw material specifications, releasing product only based on test results.

Update and implement compliance standards according to GMP requirements.

Work with QC, management and other departments to review and approve quality documents, assuring  finished products and bulk ingredients comply with supplier, customer, and FDA specifications.

Ensure that all non-conforming products are quarantined and disposed of.

Develop and deliver cGMP quality training to the entire plant and all its personnel.

Preferred Skills

BS Degree in chemistry and/or life sciences.

5 years’ experience as a QA Manager/Supervisor in a GMP manufacturing environment

Ability to lead, direct, manage and develop others.

Knowledge of relevant SOP’s, cGMP and regulatory guidelines.

Knowledge of FDA regulatory activities.

Organizational skills and ability to prioritize.

Ability to work in a team and as an individual.

Preparation and control of product Information.

Familiar with root cause analysis or problem solving tools.

Experience with quality risk assessment.

Proven experience in QA environment.

Possess excellent computer skills: Excel / Word / Power-Point

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.



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