Quality Manager
Job#: 3035333
Job Description:
Quality Manager
Growing cosmetics company is expanding their team and adding a Quality Manager to start quickly to support their manufacturing operations. This role will have approximately 12 direct reports, work full time during the day, and be a key contributor. We value our team members and support their voice in prioritizing the quality of our products.
Summary: Oversees all Quality Assurance (QA) and Quality Control (QC) operations. They ensure products consistently meet safety, efficacy, and regulatory standards (following cGMP, MoCRA and ISO 22716), managing compliance audits, product testing, and continuous quality improvement across all aspects of operations from incoming materials to outgoing finished goods. Quality is a proactive program – ensure that policies and procedures are in place to prevent defects with a focus on processes used to make the product.
Essential Duties and Responsibilities:
· Regulatory Compliance: Ensure all production and testing processes align with cGMP, MoCRA, and ISO 22716 and maintain proper documentation of all system activities.
· Quality Management Systems (QMS): Help develop, implement, and maintain robust QMS protocols. Handle document control, calibration of equipment, and change management. Improve the development of processes to improve product quality.
· Testing & Release: Oversee the inspection of incoming raw materials, in-process goods, and final finished products. Authority to place holds on or release batches and finished goods based on specification adherence.
· CAPA & Root Cause Analysis: Lead investigations into deviations, out-of-specifications (OOS) results, and customer complaints to drive Corrective and Preventive Actions.
· Supplier Quality: Work collaboratively with the supply chain team to audit and evaluate raw material vendors.
· Team Leadership and Cross-functional Collaboration: Manage, train, and mentor QA/QC personnel, Quality Supervisors, and ability to seamlessly work with R&D, operations, regulatory affairs, and purchasing departments.
· Decision-Making Authority: Must possess the confidence and authority to halt manufacturing or stop product release if quality is compromised.
Direct Responsibilities:
· The test and release of all in-process products, raw materials, and finished goods for internal use or shipment to the customer
· Maintaining all the programs and documentation required when the company is audited.
· Creation of all Production Filling master documents.
· Using proper change control procedures when changing master documents with proper history maintained throughout. All records will be maintained in the master files.
· Work directly with customer service or the customer as needed to establish their specifications and requirements.
· Ensure that all customer requirements are documented in master records so that the production floor has all instructions required to produce the product accordingly.
· All documents and processes will be created as part of the quality system.
· Manage all incoming, in-process and Finished Goods sampling and testing programs.
· Assisting with customer complaints, investigations, and follow up as needed.
· SOP auditing for adherence to policy.
· Internal Facility auditing for compliance and cGMP.
Internal GMP auditing includes reporting results and tracking corrections
· Manage the Pest Control program to ensure service is performed correctly. Notify operations of any deficiencies or blocked traps and document correction for next Pest Control visit. There should be no repeat occurrences.
· Qualify and monitor all external labs for compliance.
· Review of Calibration receipts to ensure service was performed. Audit to ensure all labeling placed on equipment by calibration service is accurate and matches SOP requirements.
· Perform or oversee the performance of all water system testing and monitoring.
· Audit water system maintenance to ensure service was performed and within parameters.
· Initiate and carry out OOS and Non-Conformance investigations.
· Implement CAPA as needed and follow up to ensure preventative action is in place and adequate.
· Update and manage the Environmental Monitoring program.
· Annual product review completion for OTC /Medical Device products.
· Monitor and execute Training programs for Plantwide compliance and personnel development.
· Actively pursue continuous improvement of policies and procedures.
· Attention to detail - keen eye for reviewing batch records, testing data, and specifications.
· Other duties will be assigned as needed.
Management Responsibilities: Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include planning, assigning, and directing work; addressing complaints and resolving problems.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience: Five or more years of progressive quality leadership experience within the cosmetics, personal care, or topical OTC manufacturing space, preferably with strong formulations and product ingredient background. Experience with Contract Manufacturing a plus. Bachelor’s degree in chemistry, biology, chemical engineering, or a related scientific field is strongly preferred.
Language Ability: Ability to read, analyze, and interpret common scientific and technical journals, reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or the business community. Ability to write and speak clearly and effectively. Ability to effectively present information to top management, public groups, and/or regulatory agencies.
Math Ability: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The employee may occasionally lift and /or move up to 25 pounds. While performing the duties of this Job, the employee is regularly required to walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; reading and proofreading for accuracy.
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
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