QA Specialist

HELP US BRING THE GIFT OF HEALTH TO LIFE.

Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to work on the #1 selling national vitamin and supplement brand, Nature Made, as well as an exciting portfolio of other products that are shaping the future of the healthy living industry. Consumer-driven innovation, high quality products and a promising portfolio, all driven by a team with a shared sense of purpose -- that's Pharmavite. Join us to bring the gift of health to life.

QA Specialist - Days (No Sponsorship)

New Albany, Ohio

Position Summary:

Collects, categorizes, and evaluates quality data from manufacturing, reprocessing, packaging processes and the accompanying documents to support Quality and company metrics. Supports Quality Assurance programs and activities, including internal audits, non-conformance investigations, and corrective and preventative action (CAPA) implementation and monitoring. Maintains a critical mindset involving data and process interpretation from material receipt through inspection and post-commercial release. Additional duties include,  cross-functional improvement projects and developing timely, accurate, thorough reports for various levels of the organization.

Responsibilities:

• Analyze data to identify areas of improvement in the process, especially related to reduction of non-conformances and deviations.

• Lead and/or collaborate on non-conformance and CAPA investigations.

• Drive root cause identification, analysis, and containment action with urgent, but thorough investigations.

• Make clear recommendations for corrective actions based on collaboration and expertise.

• Write clear, thorough, and accurate reports and investigations appropriate for internal distribution.

• Communicate results, metrics improvements, and necessary escalations to Quality and other department area leaders and/or managers effectively. 

• Conduct, track and communicate training needs especially in support of Quality and Compliance.

• Perform risk-based internal GMP audits and CAPA reports as appropriate.

• Provide subject-matter and functional support to internal & external partners.

• Work collaboratively to identify and resolve discrepancies in and around manufacturing.

• Evaluate existing Quality documentation and procedures for compliance and accuracy.

• Update and create documents and procedures as needed to support manufacturing and the quality systems.

• Remain aware of and ensures ongoing compliance to internal and industry regulatory requirements.

• Able to effectively prioritize work to meet deadlines.

• Support department, site, and company KPIs, pQRFT and dQRFT metrics.

• Perform other duties as assigned.

Minimum Qualifications:

Education:

4-year college degree in related science field or equivalent industry experience with course work in biology or chemistry and mathematics required.

Certification:

Licenses or certifications are not required but are a plus.

Experience:

A minimum of three years experience in quality or related inspection/investigation activities preferably in a manufacturing environment or an FDA regulated industry.

Knowledge/Skills/Abilities:

Requires:

• Ability to problem solve and troubleshoot manufacturing issues related to quality and/or operational issues while meeting deadlines.

• Ability to communicate effectively, verbally and writing with multiple levels of employees (employees, leader, manager, etc.) and across multiple functions.

• Subject matter expert in their work area to aid in identification of sustainable solutions to address systemic issues.

• Working knowledge of equipment, safety, quality and computer systems.

• Strong interpersonal, written and oral communications skills.

• Statistical and mathematical skills are preferred.

• Ability to understand product specifications and how they relate to product manufacturing.

Requirements: 

General office environment, ability to sit for long periods of time and pay intense and close attention to detail.  Ability to move about an office and a manufacturing facility.