Person In Plant

Our client, a large global pharmaceutical company, has an immediate need for an energetic Person in Plant, Quality Assurance to join the team. The Person in Plant is responsible to ensure that products manufactured meet Company Consumer quality and compliance expectations. The product portfolio consists of topical OTC drugs and cosmetic formulations. This position provides on-site oversight of the end-to-end manufacturing and associated operations for Company products. This Person in Plant will also provide risk-based QA direction, perspective and support to a range of technical, compliance and business issues pertinent to products and materials manufactured, tested and/or stored at the facility.

If you have excellent communication and the following skills, we would love to speak with you!

Job Responsibilities:

• Responsible for ensuring overall compliant operations at the site. Routine presence on the shop floor is necessary
• Review and approve site investigations, CAPA and all other quality systems documents
• Understanding of batch records
• Provide expertise, oversight, mentoring, and guidance to the site where required to help develop expertise and drive competency development across the site
• Monitor and react decisively to trends noted in non-conformance events, CAPAs, and other quality/compliance indicators
• Provide oversight to key quality & compliance improvement initiatives where applicable such as Electronic Label mix-up prevention, electronic pre-weigh systems, robust product release systems, implementation of WWSP/QSP/SOP requirements, etc.

• Knowledge and understanding of micro-lab operations, provide oversight of the micro lab onsite and ensure that procedures and requirements are met

• Walk the floor to ensuring that there are no plant hygiene issues, and that the equipment is being appropriately cleaned and sanitized
• Knowledge and experience with manufacturing, and understanding of how equipment should be adequately cleaned, sanitized and maintained
• Ensure that water system data and environmental monitoring data is good with no issues
• Track cleaning & sanitization frequencies to ensure they are adhered to
• Track preventive maintenance frequencies
• Track corrective actions and ensure they are implemented on time by the team
• General knowledge of GMPs and controls required for cosmetics or pharmaceuticals
• Knowledge and understanding of mix-up prevention is preferred

Qualifications:

• A minimum of a Bachelor's degree is required
• A focused degree in a Science related discipline is preferred
• A minimum of 2 years of experience working in a regulated industry is required
• Experience in either Cosmetics, or Personal Care Products production, Pharmaceutical, or OTC
• Working knowledge of cGMP requirements, current FDA enforcement issues and current regulatory authority enforcement practices is required
• Working knowledge of process validation, cleaning validation, manufacturing and packaging equipment train designs, microbiological controls, and assessing compliance to regulations is required
• Plant Quality experience is preferred
• Experience in the facilitation of internal and external audits and regulatory inspections is preferred

Knowledge, Skills and Abilities:

• Demonstrated ability to build respectful and productive relationships with subordinates, peers and leadership partners across multiple responsibility levels and within a matrix structure
• Strong communication (verbal, written, and presentation) and interpersonal skills
• Demonstrated ability to address complex issues using deductive reasoning, critical analysis skills and systematic approaches
• Demonstrated working knowledge of root cause analysis techniques, and CAPA

Demonstrated ability to build respectful and productive relationships with subordinates, peers and leadership partners across multiple responsibility levels and within a matrix structure

Benefits

A comprehensive benefits package which includes medical, dental, vision, disability and life insurance, 401k and a generous PTO Policy.

About Endeavor:

At Endeavor Consulting Group, our mission is to provide straightforward solutions to complicated situations. As a specialty project management technology and integration firm, we are laser focused on Operational Systems, Supply Chain Integration, and Product Development for Life Sciences enterprises. Our team is