Hourly Fda Auditor Jobs (NOW HIRING)

COMPANY OVERVIEW:

Balchem Corporation develops, manufactures, and markets specialty ingredients that improve and enhance the health and well-being of life on the planet, providing state-of-the-art solutions and the finest quality products for a range of industries worldwide. Our corporate headquarters is located in Montvale, New Jersey and we have a broad network of sales offices, manufacturing sites, and R&D centers, primarily located in the US and Europe. Founded in 1967, Balchem is a publicly traded company (NASDAQ – “BCPC”) with annual revenues over $900 million and a market cap exceeding $4.0 billion. The company consists of three business segments: Human Nutrition & Health; Animal Nutrition & Health; and Specialty Products. Balchem employs over 1,400 people worldwide who are engaged in diverse activities, committed to developing the company into global market leadership positions. To learn more about our dynamic, stable and growing company, visit www.balchem.com.

POSITION SUMMARY: This Entry Level Hourly position is located in Bridgeton, MO

Under the direction of the Quality Supervisors, provide support for quality system activities to assure conformance to established specifications and compliance to FDA 21 CFR 117/111 regulation and certificate standards. Work on projects regarding external regulations, agency guidelines, and internal policies to assure compliance. Facilitate the optimization and continuous improvement of internal quality systems to meet department and company objectives. Assist in maintaining quality systems when assigned.

Key Responsibilities:

Activities Supporting Supply Chain Delivery: Ensuring execution of day-to-day activities supporting supply chain. This may include but is not limited to release, testing, reviewing, troubleshoot and complete verifications/validations/calibrations as required.

Compliance & Performance: 40%

Ensuring execution of food safety and 3rd party requirements. Responsible for performance and KPIs through auditing, execution, follow-ups. Demonstrates ability to prioritize and bring visibility to non-conformances and key drivers impacting KPI’s, assign actions to contain, correct, prevent. Identify operational excellence opportunities and proactively execute on initiatives.

Escalated Issue Management: 30%

Responsible for identifying and escalating and collaborating on non-conformances. Servicing equipment, Internal Defects and external complaints including root cause and CAPA investigation, completion and effectiveness checks.

Optimization & Culture: 20%

Supporting operational excellence, continuous improvement activities across the site. Supporting and participating in internal audits. Taking part in engaging and developing cross functional team members.

Secondary Responsibilities: 10%

• Partnership with site leaders and cross functional partners for goal setting, decision-making alignment, and training and development needs
• Supports Commercialization functions & process as needed
• Coordinate completion of MSS, Record Review, Verifications, and Calibrations
• Supporting execution of audits and delivering system updates.
• Provide backup support as needed in the department.
• Effective deployment of quality strategies across site.

People:

• Responsible for supporting development and performance of the site quality team.
• Builds strong cross functional relationships and demonstrates ability to effectively influence site strategy & execution.
• Develops a culture that drives quality improvements and efficiently interfaces with operational excellence processes.
• Deliver and keep current training programs focused on food safety and quality.
• Timely escalation and communication of food safety, quality, financial issues.
• Motivates and builds team strength.

Systems:

• Responsible for the effective application of site Product Safety, Product Quality and prerequisite systems. Ensure these systems effectively interface with change control and commercialization processes.
• Strong ability to root cause issues and prevent recurrence via persistent pursuit of higher hierarchical levels of control than administrative, including but not limited to formula, engineering, and elimination strategies.
• Responsible for supporting an effective internal audit program and that corrective actions are completed
• Collaborates with R&D, Production, and commercial teams in the development and preparation for production of new Products, Processes, and Equipment to support new product/customer launches.
• Interface with operational excellence programs to maximize effectiveness
• Coordinates with site leaders in preparation for customer visits and external audits
• Ability to become site power user for ERP & LIMS systems.

Knowledge & Experience:

• Operated in an FDA regulated environment, ideally food or dietary supplement
• Assess and mitigate food safety, regulatory, and cost risks.
• Apply sanitation principles effectively.
• Effective project manager that knows how to prioritize and meet deadlines
• Execution of CAPA and Customer Complaint system.
• Demonstrated ability to understand and organize technical data for communications and analysis

REQUIREMENTS:

• Bachelor’s degree in a science-related field
• 1+ years of experience in food, supplement, or related industry.
• Ability to lift 50 lbs.; required to stand, walk, sit, and reach.
• Ideal Candidate:
  • Familiarity with FDA
  • GFSI Scheme (i.e. SQF, BRC)
  • Certification focused on Quality and Food Safety for Supply Chain requirement: PCQI

Balchem is committed to a workplace culture that values and promotes diversity, inclusion, equal employment opportunities, and a work environment free of harassment and hostility.