Quality Manager - Personal Care Manufacturing

Job Description Summary

Handles the Quality Assurance activities to ensure that policies and procedures are in place to prevent defects with a focus on processes used to make the product. Quality Assurance is a Proactive program.

• Improve the development of processes to improve product quality.
• Perform audits of the quality system to assess its adequacy.
• Prevention of quality problems through planned and systematic activities.
• Maintaining proper documentation of all system activities.

• The test and release of all in process products, raw materials, and finished goods for release for internal use or shipment to the customer.
• Maintaining all the programs and documentation required when the company is audited.
• Creation of all Master Batch and Production Filling master documents. These documents require 3 signatures, final signature will be the Director of Quality.
• 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.
• Assisting with customer complaints, investigations, and follow up as needed.
• SOP auditing for adherence to policy.
• Facility auditing for compliance.
• Internal GMP auditing.
• Review of the Pest Control receipts to ensure service was performed correctly.
• Review of Calibration receipts to ensure service was performed.
• Perform or oversee the performance of all water system testing and monitoring.
• Audit water system maintenance to ensure service was performed and within parameters. li>
  
  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.
• Annual product review completion.
• Actively pursue continuous improvement of policies and procedures.
• Other duties will be assigned as needed.

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.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

Minimum of 3 years in a personal care manufacturing environment specifically in R&D, Quality and Regulatory, preferably with a strong formulations and product ingredient background. Experience with Contract Manufacturing a plus. Or a background suitable to training in this industry. Must be proficient with MS Office. An undergraduate degree in chemistry is strongly preferred.

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.

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.

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.

The physical demands…