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Description

• Ensure 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).  Maintain and oversee the Quality Management System (QMS), including SOPs, work instructions, and quality manuals.  Manage regulatory inspections (FDA, state, third-party audits) and coordinate responses to findings.  Stay updated on relevant regulatory changes and ensure facility compliance.  Review and approve Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) for accuracy and compliance.  Oversee and approve in-process checks (pH, viscosity, microbial limits, fill weights).  Ensure that line clearance and changeover procedures are properly executed.  Supervise incoming raw material testing (identity, potency, microbiological, heavy metals if applicable).  Oversee finished product testing to ensure products meet specifications.  Review and approve Certificates of Analysis (CoA) from third-party labs.  Approve and maintain the Approved Supplier Program.  Conduct supplier qualifications, audits, and periodic reviews.  Ensure proper raw material traceability and adherence to quality specifications.  Investigate deviations, non-conformances, and customer complaints.  Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).  Manage change control for processes, materials, and equipment affecting product quality.  Train staff on cGMP, SOPs, hygiene, and quality standards.  Maintain training records and ensure ongoing competency of production and quality teams.  Ensure proper documentation practices (GDP).  Maintain and archive all quality records, batch documentation, and testing results per regulatory requirements.  Monitor and ensure compliance with sanitation and cleaning validation protocols.  Oversee environmental monitoring for microbial contamination (particularly for liquid products).  Make final product disposition decisions (release, reject, or hold).  Participate in product recall investigations and ensure recall procedures are in place.  Identify process improvements to enhance product quality, efficiency, and compliance.  Participate in cross-functional meetings to ensure quality considerations are integrated into production planning.

Skills

Gmp, fda, audit, cgmp

Additional Skills & Qualifications

- Knowledge of Excel, Word, and Adobe software. - Communication and management skills. - Ability to manage, carryout, and prioritize departmental functions. - Ability to see areas that need improvement and to address them. - Extensive background in quality systems and food and beverage manufacture.

Experience Level

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 [email protected] (%[email protected]) for other accommodation options.