Orlando, Florida, USA
2 days ago
Quality Operations Manager

Description

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\tEnsure facility compliance with cGMP regulations (21 CFR Part 111 for dietary supplements, 21 CFR 210/211 for OTC drugs if applicable, and ISO 22716 for skin care).\tMaintain and oversee the Quality Management System (QMS), including SOPs, work instructions, and quality manuals.\tManage regulatory inspections (FDA, state, third-party audits) and coordinate responses to findings.\tStay updated on relevant regulatory changes and ensure facility compliance.\tReview and approve Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) for accuracy and compliance.\tOversee and approve in-process checks (pH, viscosity, microbial limits, fill weights).\tEnsure that line clearance and changeover procedures are properly executed.\tSupervise incoming raw material testing (identity, potency, microbiological, heavy metals if applicable).\tOversee finished product testing to ensure products meet specifications.\tReview and approve Certificates of Analysis (CoA) from third-party labs.\tApprove and maintain the Approved Supplier Program.\tConduct supplier qualifications, audits, and periodic reviews.\tEnsure proper raw material traceability and adherence to quality specifications.\tInvestigate deviations, non-conformances, and customer complaints.\tLead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).\tManage change control for processes, materials, and equipment affecting product quality.\tTrain staff on cGMP, SOPs, hygiene, and quality standards.\tMaintain training records and ensure ongoing competency of production and quality teams.\tEnsure proper documentation practices (GDP).\tMaintain and archive all quality records, batch documentation, and testing results per regulatory requirements.\tMonitor and ensure compliance with sanitation and cleaning validation protocols.\tOversee environmental monitoring for microbial contamination (particularly for liquid products).\tMake final product disposition decisions (release, reject, or hold).\tParticipate in product recall investigations and ensure recall procedures are in place.\tIdentify process improvements to enhance product quality, efficiency, and compliance.\tParticipate in cross-functional meetings to ensure quality considerations are integrated into production planning.

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Skills

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Gmp, fda, audit, cgmp

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Additional Skills & Qualifications

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-\tKnowledge of Excel, Word, and Adobe software.-\tCommunication and management skills.-\tAbility to manage, carryout, and prioritize departmental functions.-\tAbility to see areas that need improvement and to address them.-\tExtensive background in quality systems and food and beverage manufacture.

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Experience Level

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Expert Level

Pay and Benefits

The pay range for this position is $110000.00 - $140000.00/yr.

Health, Dental, Vision, 401K Benefits for this position.

Workplace Type

This is a fully onsite position in Orlando,FL.

Application Deadline

This position is anticipated to close on Jul 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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