Quality Specialist

Position Summary:

The Quality Specialist will assure the quality of production by developing and enforcing good manufacturing practices (GMP); they will also validate processes, create and update SOP’s and production documentation, and train production and packaging staff as needed. This position collaborates with the senior management and production departments to ensure that quality standards are met for all production which occurs at the facility.

Responsibilities:

The Quality Specialist will ensure that production is carried out in a manner which is consistent with required GMP and Quality Systems. Key duties and responsibilities include:

• Participate and contribute to continuous improvement of departmental SOPs
• Conduct stability, testing, and retain programs for all products and raw materials; serve as liaison between the company and multiple testing facilities
• Apply advanced analytical knowledge including sample preparation techniques, instrumentation, and reporting for dietary supplement analysis
• Manage CAPA/OOS/Investigation and Change Control programs for quality-related issues
• Perform quality checks including label control and verification, raw material qualification, and pest control oversight
• Create and control production documentation including MMR, BPR, specifications, CoAs, test records, and TDS
• Oversee sanitation and equipment programs; assist with enforcement of allergen and cross contact/contamination programs
• Monitor required elements of HACCP/Food Safety Plans
• Author SOPs and supervise data collection, reporting, and recommendations for improvement
• Serve as member of Product Recall team and facilitate quality-focused meetings

Qualifications

• 1 years QA/QC experience in GMP setting (pharma, dietary supplements, or food)
• Detailed knowledge and track record of successful implementation of dietary supplement manufacturing policies and procedures
• Capable of measuring, monitoring, documenting and communicating results; and making corrective actions
• Excellent written, verbal, and interpersonal communication skills with ability to work with diverse personality types
• Exceptional organizational skills
• Expertise with major business software applications (Adobe, Microsoft Office, etc.)
• Ability to make decisions under pressure and multi-task, supervising multiple projects concurrently
• Basic statistical tools knowledge and application
• Willingness to embrace change, adapt strategies, and pursue continuous improvement
• BS in Chemistry, Engineering, Microbiology or related field

Bonus Skills

• PCQI, HACCP, FDA 21 CFR 111, FDA 21 CFR 117 knowledge
• Bilingual in Spanish
• Manufacturing/Production experience
• Leadership experience