Compounding Manager

McKenna Labs, Inc•Fullerton, CA

1d•Onsite

About The Position

McKenna 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. We are seeking an experienced Compounding Manager. The Compounding Manager leads the company's Compounding and Pre-Weigh teams and serves as the subject matter expert (SME) on compounding operations within a regulated personal care and OTC manufacturing environment. This role carries primary accountability for the safety of personnel, the integrity of every batch produced, and full compliance with cGMP, ISO 22716, FDA, OSHA, and applicable federal and state regulations. The Compounding Manager ensures that every batch released from the compounding floor is manufactured to specification, fully documented, free from contamination, and consistent in identity, strength, quality, and purity. In addition to driving batch quality and process safety, the Compounding Manager is responsible for optimizing production processes, implementing cost-effective solutions, and leading continuous improvement initiatives that strengthen the company's quality system and operational performance.

Requirements

Bachelor's degree in Chemistry, Chemical Engineering, Material Science, Biology, or a closely related scientific or engineering discipline preferred; equivalent combination of education and progressive industry experience will be considered.
Minimum of 10 years of relevant compounding experience with 7+ 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.
Demonstrated expertise in compounding processes including emulsions, suspensions, solutions, gels, creams, lotions, surfactant systems, and anhydrous formulations, with practical knowledge of mixers, homogenizers, kettles, vacuum systems, heating/cooling jackets, and transfer systems.
Proven ability to read, interpret, and execute master batch records, formulas, SOPs, P&IDs, and equipment manuals, and to coach others to do the same.
Strong working knowledge of root cause analysis tools (5 Whys, Fishbone, Fault Tree), CAPA development and effectiveness verification, change control, deviation management, and OOS investigation procedures.
Familiarity with 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 process, resource management, or new technology.
Excellent cross-functional collaboration skills with the proven ability to partner effectively with Quality Assurance, Quality Control, R&D, Regulatory Affairs, Supply Chain, Engineering, Maintenance, EHS, and Warehouse leaders.
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) and familiarity with ERP/MES systems (e.g., SAP, Oracle, NetSuite) and electronic batch record systems.
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.

Nice To Haves

Bilingual proficiency in technical Spanish

Responsibilities

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 Compounding and Pre-Weigh 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, batch record execution, sanitation, chemical handling, equipment operation, weighing and measurement accuracy, 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.
Champion a zero-incident safety culture across all compounding and pre-weigh operations; lead by example in observing every safety rule, lockout/tagout procedure, and PPE requirement.
Ensure safe handling, weighing, transfer, and storage of all raw materials, including hazardous chemicals, fragrances, surfactants, solvents, acids, bases, powders, and pressurized systems, in accordance with Safety Data Sheets (SDS), GHS labeling, and OSHA Hazard Communication standards.
Verify that the compounding area is 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).
Ensure mechanical integrity of mixers, kettles, homogenizers, scales, pumps, hoses, and pressure vessels through partnership with the Maintenance team on preventive maintenance, calibration, and equipment qualification.
Maintain readiness for emergency response, including chemical spills, fires, and product or material reactions; ensure team members know evacuation routes, MSDS/SDS locations, and reporting protocols.
Hold ultimate operational accountability for the quality of every batch produced; ensure each batch is manufactured strictly to the approved Master Manufacturing Record, formula, processing parameters, and in-process specifications.
Verify that all raw materials issued to the compounding floor are released by Quality Control (QC), correctly identified, within expiration/retest date, and accurately weighed by the Pre-Weigh team prior to addition.
Ensure rigorous batch record execution, including real-time documentation, contemporaneous signatures, second-person verification of critical steps (additions, weights, temperatures, mix times, pH, viscosity, specific gravity), and adherence to ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Monitor and control critical process parameters (CPPs) and critical quality attributes (CQAs) throughout each batch, including temperature, mixing speed and duration, order of addition, hold times, and homogenization conditions.
Coordinate in-process and final batch sampling with Quality Assurance/Quality Control; review test results (pH, viscosity, color, odor, appearance, microbiological, active assay where applicable) and authorize batch adjustments only within the limits permitted by the approved batch record.
Ensure all batches are properly identified with lot numbers, status labels (quarantine, in-process, approved, hold, rejected), and are stored under conditions that preserve product quality pending QA release.
Partner with QA on batch record review, batch disposition, and timely closure of any batch deviations, out-of-specification (OOS) results, or out-of-trend (OOT) observations.
Lead and participate in non-conformance investigations, customer complaint investigations, and product return evaluations; own root cause analysis and the development, implementation, and effectiveness verification of CAPA plans.
Ensure full compliance with cGMP (21 CFR Part 210/211 where applicable), ISO 22716 (Cosmetics – Good Manufacturing Practices), FDA Modernization of Cosmetics Regulation Act (MoCRA) requirements, and all internal SOPs.
Maintain inspection-ready documentation at all times; serve as a primary subject matter expert and front-room or back-room resource during internal audits, customer audits, and regulatory inspections.
Establish and enforce robust sanitation programs covering compounding tanks, kettles, mixers, transfer lines, hoses, fittings, scoops, scales, and the surrounding manufacturing environment to prevent cross-contamination, microbial contamination, and product carryover between batches.
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 compounding 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.
Oversee day-to-day compounding manufacturing activities to support the production schedule, ensuring batches are made on time, in full, and in compliance with all quality and safety requirements.
Partner with Planning, Supply Chain, and Production to balance schedule attainment with batch quality, never permitting schedule pressure to compromise safety, GMP compliance, or batch integrity.
Manage labor allocation, shift coverage, and overtime in the compounding and pre-weigh areas to deliver consistent throughput while controlling labor costs.
Provide oversight for the development, maintenance, and periodic review of compounding manufacturing programs, systems, processes, SOPs, and work instructions to ensure conformance to internal and external standards.
Analyze and present operational, safety, and quality data to senior management to ensure that resources are sufficient and that projects are appropriately prioritized in alignment with manufacturing requirements and business goals.
Collaborate with Quality, R&D, Engineering, and external partners to analyze production processes, identify opportunities for improvement in efficiency and productivity, and develop and standardize best practices that drive both compliance excellence and operational efficiency.
Work closely with Production and Operations teams to streamline workflows, reduce changeover times, and eliminate bottlenecks without compromising safety or batch quality.
Review and approve, in partnership with QA and R&D, all proposed changes to formulas, processes, equipment, or materials through the formal Change Control system, including risk assessment of impact on safety, quality, and validation status.
Drive continuous improvement initiatives — leveraging Lean Manufacturing, Six Sigma, 5S, Kaizen, and similar methodologies — to optimize batch yield, reduce waste and scrap, lower right-first-time failures, and increase overall equipment effectiveness (OEE).
Apply manufacturing management principles to troubleshoot complex technical issues (e.g., batch failures related to viscosity, emulsion stability, color, fragrance loading, pH drift, or microbial excursions) and provide innovative, science-based solutions.
Lead and review studies for the qualification and implementation of new equipment, technologies, and processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and process validation in coordination with Quality and Engineering.
Track and report key performance indicators (KPIs) including batch right-first-time, deviations per batch, OOS rate, cycle time, scrap, recordable safety incidents, and on-time batch completion.