Cleaning and Sanitization Manager
hace 18 días
Fullerton
Job DescriptionMcKenna Labs is a full-service contract manufacturing company that specializes in hair, skin and body care products. We've been in the personal care development and manufacturing industry since 1998. Summary The Cleaning & Sanitization Manager leads the company's Sanitization and Janitorial teams and serves as the subject matter expert (SME) on contamination prevention within a regulated personal care and OTC manufacturing environment. This role carries primary accountability for the safety of personnel, ensures facilities, equipment, and processes are in full compliance with cGMP, ISO 22716, FDA, OSHA, and applicable federal and state regulations to prevent contamination and ensure product safety, quality, and compliance. In addition to driving product quality and process safety, the Cleaning & Sanitization Manager is responsible for optimizing processes, implementing cost-effective solutions, and leading continuous improvement initiatives that strengthen the company's quality system and operational performance. Key Responsibilities include Leadership and Team Management • Carry out responsibilities in compliance with company policies, work procedures, and federal, state and local laws. Comply with Good Manufacturing Practices (GMPs), and health and safety rules and regulations., • Provide strong, hands-on leadership to Sanitization and Janitorial team members, fostering a culture of safety-first behavior, quality ownership, accountability, collaboration, and continuous improvement., • Build department capability and capacity to meet both current and future business needs through talent acquisition, structured employee training and development, succession planning, and performance management., • Set clear safety, quality, and productivity goals; monitor performance against targets; and provide timely, constructive feedback and coaching to team members., • Develop and deliver comprehensive training programs covering cGMP, ISO 22716, sanitation, chemical handling, equipment operation, and personal protective equipment (PPE) use., • Verify that all team members are qualified and re-qualified on the specific equipment, products, and procedures they execute, and maintain auditable training records for each employee., • Contribute to an environment in which all team members are respected regardless of their individual differences. Safety of People, Process, and Product • Champion a zero-incident safety culture across cleaning and sanitization operations; lead by example in observing every safety rule, lockout/tagout procedure, and PPE requirement., • Ensure safe handling, weighing, transfer, and storage of all chemicals in accordance with Safety Data Sheets (SDS), GHS labeling, and OSHA Hazard Communication standards., • Verify that the wash areas are equipped with, and that operators are trained on, emergency eyewashes, safety showers, spill containment, fire suppression, ventilation, and proper grounding/bonding for flammable materials., • Lead daily safety walks, behavior-based safety observations, and pre-shift toolbox talks; immediately address unsafe conditions or behaviors and drive permanent corrective action., • Investigate all safety incidents, near misses, and ergonomic issues in the compounding area; perform thorough root cause analysis (RCA) and implement effective corrective and preventive actions (CAPA)., • Maintain readiness for emergency response, including chemical spills, fires, and product or material reactions; ensure team members know evacuation routes, SDS locations, and reporting protocols. Sanitation, Contamination Control, and Hygiene • Develop, implement, and enforce robust sanitation and hygiene programs for manufacturing, production, laboratory, warehouse, and support areas to prevent cross-contamination, microbial contamination, and product carryover between jobs., • Verify cleaning effectiveness through visual inspection, swab testing, rinse sample analysis, and ATP monitoring as defined in cleaning validation protocols; ensure changeover cleaning meets validated acceptance criteria before the next product is introduced., • Enforce gowning, hand hygiene, jewelry, and personal hygiene standards consistent with cGMP and ISO 22716 expectations; control access to washroom areas and ensure visitor and contractor compliance., • Oversee management of the water system used in compounding (purified water, deionized water, or USP water as applicable), including monitoring of microbial and chemical quality and timely response to any excursion., • Ensure proper segregation, identification, and disposal of waste streams, rejected materials, and returned product to prevent commingling with approved inventory., • Evaluate and recommend new cleaning technologies, tools, and detergents. Operations and Scheduling • Oversee day-to-day cleaning activities to support the production schedule, ensuring equipment is available on time and in compliance with all quality and safety requirements., • Partner with Planning and Production to balance schedule attainment with cleaning quality, never permitting schedule pressure to compromise safety, GMP compliance, or product integrity., • Manage labor allocation, shift coverage, and overtime in the cleaning and sanitation areas to deliver consistent output while controlling labor costs., • Provide oversight for the development, maintenance, and periodic review of cleaning and sanitation programs, systems, processes, SOPs, and work instructions to ensure conformance to internal and external standards. Requirements To fulfill requirements of the job successfully, an individual must be able to perform each essential duty at a high level. The requirements listed below are representative of the knowledge, skill, and/or ability required. • Bachelor's degree in Chemistry, Biology, Microbiology, Food Science, or a closely related scientific discipline preferred; progressive industry experience will be considered., • Minimum of 5-7 years of relevant sanitation experience with 2+ years of managerial experience in a regulated manufacturing environment, preferably in personal care, cosmetics, OTC, pharmaceutical, nutraceutical, or food industries., • Comprehensive working knowledge of cGMP (21 CFR Parts 210/211), ISO 22716, FDA cosmetic and OTC regulations, MoCRA, OSHA general industry standards, and Hazard Communication / GHS requirements as they relate to manufacture and quality release of personal care and OTC products., • Strong understanding of cleaning validation, process validation, equipment qualification (IQ/OQ/PQ), and risk assessment methodologies (e.g., FMEA, HACCP-style hazard analysis)., • Strong leadership and team-management skills with a demonstrated ability to deliver high-quality results in a fast-paced environment while mentoring, developing, and motivating staff across multiple shifts., • Proven track record of operating with absolute integrity around documentation, data, and reporting, and of holding teams accountable to the same standard., • Ability to provide analytical strategic vision, effectively prioritize, manage resources, and deliver high-quality results on tight timelines and within budget., • Outstanding problem-solving skills, including the ability to devise and implement practical solutions to resolve complex technical and compliance issues through improved processes, resource management, or new technology., • Excellent cross-functional collaboration skills with the proven ability to partner effectively with Compounding, Filling, Quality Assurance, Quality Control, Engineering, Maintenance, EHS leaders., • Familiarity with writing and reporting deviations and non-conformances associated with the department., • Strong written and verbal communication skills, including the ability to clearly document investigations, present data to senior leadership, and host customer and regulatory auditors., • Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint), • Fluency in English required. Bilingual proficiency in technical Spanish is a strong differentiator., • Must be able to work in person onsite, including the flexibility to support off-shift production, weekend operations, and urgent investigations as needed.Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. • Work is performed primarily in an active manufacturing environment with exposure to chemicals, fragrances, dust, noise, varying temperatures and humidity, wet floors, moving mechanical equipment, and periods of cold and high heat temperatures., • Required to stand, walk, climb stairs and ladders, bend, stoop, reach, and use hands and arms for extended periods., • Must be able to lift, push, or pull up to 50 pounds occasionally and assist with the safe movement of drums, totes, and pallets using appropriate material-handling equipment., • Required to wear all assigned PPE, which may include safety glasses or goggles, hearing protection, gloves, hairnets, beard covers, lab coats or smocks, slip-resistant footwear, and respiratory protection where required. The compensation range for this role is $89,000 - $115,000 per year. Compensation is commensurate with level of knowledge, education, skills, and experience applicable to the position. We understand that each team member’s situation is unique, and so it is our intent to offer an overall benefits package that can be shaped and molded by each individual to fit their family’s needs. Our current benefits package, which is available to all full-time team members, includes medical, dental, vision insurance, 401k retirement plan, flexible spending accounts, life and disability coverage, and other voluntary benefits. We want everyone to feel welcome, respected and we are committed to providing the best space, experience and workplace for our teams – no matter what race, color, religion, sex, sexual orientation, gender identify, national origin, veteran or disability status and all the other fascinating characteristics that make us different.
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