Quality Team Member 2 (I)

Quality Team Member 2 (I)

NBTY, Inc | San Antonio, TX, 78245, US
Salary Range:$49,000 – $80,000 Salary range estimated by Zippia

Posted 8 days ago

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Job Description

Company Description

The Bountiful Company, a Nestlé Health Science Company, is a pure play branded leader in global nutrition, living at the intersection of science and nature. As a manufacturer, marketer and seller of vitamins, minerals, herbal and other specialty supplements, and active nutrition products, we are focused on enhancing the health and wellness of people's lives. The Bountiful Company's portfolio of trusted brands includes Nature's Bounty, Solgar, Osteo Bi-Flex, Puritan's Pride, Sundown and Ester-C.

Inclusion and Diversity in the workplace matters at The Bountiful Company. This includes being focused on retaining and recruiting a diverse workforce and building a culture of inclusivity. Our goal is to create a place where people feel respected, valued and able to bring their authentic selves to work each day.

Did we mention that we also offer excellent benefits, competitive compensation and a progressive, healthy company culture? If you've ever spent your workdays watching the clock, you know how important a positive work environment is for a person's well-being. The Bountiful Company is committed to supporting wellness in all forms. And when it comes to wellness, nature is a pretty good place to start.

Job Description

Under the direction of the Quality Manager, this position is responsible for ensuring products are being produced in a manner that meets all cGMP and Product Specification criteria. This position drives First Pass Quality KPI and adherence to cGMP's on the production floor at all times. The position is the Quality Unit support on the plant floor and must approve all line/room clearances prior to subsequent batch initiation. The colleague provides real time review of in-process test data and batch documentation in order to limit the need for later review or rework. The colleague is the Quality expert on the production floor and will work with the teams and advise as necessary on cGMP's and Good Documentation Practices to ensure timely release of product or reaction to issues. Adherence to Standard Operating Procedures (SOP's) is required.

Responsibilities include but are not limited to:

* Includes all responsibilities from Team Member and Team Technician
* Supports site DDS meetings and OGSM goal attainment
* Leads root cause analyses and basic problem solving discussions. Documents the results in the adequate template, 5 Why, Fishbone, etc.
* Populates the Quality Dashboard, tracks and trends site KPI data i.e. drying room temperatures, warehouse temperatures, etc.
* Is the site Super User for the PQM program and can train associates as needed.
* Performs mock recalls and traceability exercises as needed
* Ensures accurate and timely completion of batch documentation review to ensure real-time compliance to product specifications, good documentation practices, company SOP's and cGMPs. Coaches and retrains operations associates so corrections can be made if required. Maintain Documentation Error Logs for each associate, report trends and communicate to the Team Leaders. Work with the teams to reduce repeat occurrences.
* Manage batch record scanning and storage program. Manage MBR retrievals for R&D, audit or operations review when required for formula changes, auditor review or operational issues.
* Lead Site Investigator for all customer complaints, completes investigations and reports in PLM. Communicate issues to the teams as necessary for manufacturing controllable issues.
* Provide real-time guidance to production associates pertaining to compliance to cGMP's by monitoring gowning requirements, good documentation practices, in-process checks and defect resolutions.
* Complies with company policies and procedures and maintains regular work attendance.
* Performs daily compliance audits for responsible areas within production. Review and sign off on all operations log books.
* Manage the warehouse temperature monitoring program. Print all reports weekly and report all out of range temperature excursions. Reports trend to auditors and customers as required.
* Manage the temperature loggers for all areas, cooler, freezer, warehouse, and the drying rooms. Maintain calibration records for data loggers used in warehouse temperature monitoring and the digital thermometers in production area.
* Schedule site calibrations for all production and warehouse scales and equipment using load cells. Verify all scales as required by site SOP and maintain all calibration records.
* Leads the back room and document retrieval for all third party audits for FDA, UL, USP, State of Texas, GFCO, Internal audits, etc.
* Assist management of site SOP curriculum and training matrix with the site training coordinator.
* Responsible for conducting duties in compliance with safety rules, applicable SOP's, and cGMP Guidelines.
* Manage the environmental monitoring program. Perform all environmental air sampling, starch monitoring and water sampling weekly and monthly checks as required by the Corporate and site SOP. Ships samples and completes all reports.
* Manage SOP program. Maintain SOP and QP indices for site and the lab. Write, review and revise all SOP's as needed. Train associates on all new and revised SOP's or guidelines. Develop "I know and understand" training for all associate refresher SOP training as needed.
* Interface with internal and external groups such as, Operations, Procurement, Quality Assurance and Technical Services to assist in completion of business initiatives.
* Manage the hold program, by assisting the team in identifying issues, labelling and tracking disposition in the site Hold Log tracker.
* Responsible for bulk Sensory Evaluation and release and also Physical testing for raw materials.
* Train Operations and Quality associates on SOP, One Point Lessons and batch record documentation accuracy

Job Requirements

* Experience in the production process and/or environment is required.
* Experience in Quality Assurance Systems is preferred.
* High school diploma or GED required, Associates degree in Life Sciences or related science preferred.
* 3+ years experience with Associates degree or 7+ years related experience in lieu of a degree.
* Intermediate knowledge of PC programs, i.e. MS Office (Excel, Word, and PowerPoint) is required.
* Some ASQ basic training preferred. SQF, HACCP, GMP Food Safety training preferred, 1 certification preferred.
* Basic computer skills including a working knowledge of MS Word, Power Point and Excel.
* Good English verbal and written skills.
* Basic knowledge in mathematics and solving basic algebraic equations.
* Working knowledge of cGMP guidelines is preferred.
* Intermediate skills in creating and manipulating Excel spreadsheets
* Working knowledge of database work sheets (Access, etc.)
* Advanced Data Analysis, trend tracking and technical writing skills

Expected high performance behaviors:

* Exhibit positive attitude regarding work and responsibilities
* Ability to work collaboratively within teams in a High performance environment
* Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
* Continuously looks for ways to do things faster and better, while maintaining high quality standards
* Is creative and intellectually curious; tries different and novel ways to solve obstacles

Ability to lift approximately 40 pounds.

Work environment may be exposed to powders and chemicals

Ref # POS000002363