Quality Assurance Specialist coordinates GMP activities in support of commercial food and dietary supplements manufacturing and disposition. Individual will assist the management in maintaining a complete Quality Management System (QMS) in compliance to cGMPs.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Participate in and support the development, implementation and maintenance of quality assurance systems and activities.
• Provide support, coaching, training and motivation to internal staff and suggest personnel changes to increase effectiveness.
• Monitor employee training program.
• Help develop, maintain, and enforce conformity with company SOP’s and take corrective action when necessary.
• Write procedures/work instructions/specifications related to the quality management system.
• Keeps immediate supervisor well-informed of activities, results of efforts and problems identified/potential problems; recommends corrective actions to immediate supervisor.
• Assist with new supplier approvals as part of the supplier approval program.
• Attend or assist with audits and the follow up with action plans on the findings of all audits and inspections including internal compliance, external sources, vendors, providers and company audits by external sources or agencies.
• Assist in the complaint management processes; review, investigate, and prepare responses to complaints made by customers or third parties.
• Provide assistance to other personnel with regard to any Quality issues, including document retrieval and archival.
• Review nonconforming product and recommend disposition.
• Assists in regulating overall plant quality by conducting and or evaluating various product tests and tests related to ingredients and packaging, holding, and releasing product based on test results and notify supervisors or appropriate departments of discrepancies or shortages.
• Educate and instruct plant personnel in recommended quality assurance testing and equipment sanitation practices. Confirm these procedures are being maintained.
• Read, analyze, interpret, assess, and adhere to documents such as SOPs, operating procedures, company specifications and customer requirements.
• Monitor FDA and industry compliance standards, legislation, and trends, nationally and internationally and assist with ensuring an appropriate compliance program.
• Work with corresponding departments to review and approve quality documents such as master batch records, master validation protocols, stability protocols, executed batch records, executed validation protocols, specifications, and various reports, to assure that these documents conform with regulatory standards and SOPs/procedures.
• Develop and monitor effectiveness of Change Controls, Batch Record Release system.
• Document/record information by entering, recording, storing, or maintaining information in written and/or electronic form.
• Evaluate product processing and storage operations and assist in the development of quality assurance programs for such operations.
• Performs duties safely and reports unsafe conditions or actions.
• Performs and assists in other duties as needed and directed.

KNOWLEDGE

Technical/Clerical and Administrative

• Knowledge of raw materials, production processes, quality control, laws, standards, costs, and other techniques for maximizing the effective manufacture and distribution of quality and compliant goods.
• Knowledge of arithmetic including addition, subtraction, multiplication, and division, correctly in all units of measure, using whole numbers, common tractions, decimals, and percentages.

SKILLS

Reading Comprehension

Must be proficient with the English language and basic Spanish comprehension is desirable.

QUALIFICATIONS

Education/Experience

One (1) year or more of industry experience in cGMP environments or equivalent

Computer Skills

Microsoft 365 (Word, Excel, Outlook, Teams, etc.) and ability to operate other systems as needed.

Job Type: Full-time

Salary: $40,813.42 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Medical specialties:

• Dietetics

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Quality Assurance: 3 years (Required)
• CGMP: 1 year (Required)
• Food and dietary supplements manufacturing and disposition: 1 year (Required)
• Quality Management System (QMS): 1 year (Required)

Language:

• Spanish (Required)

Ability to Relocate:

• Bradenton, FL 34203: Relocate before starting work (Required)

Work Location: In person