General Description:

The incumbent is responsible for the administration of the Quality Control/Quality Assurance and Regulatory functions to assure all Total Quality System requirements are met. Responsibilities include developing an adequately trained staff of quality. The Quality Manager carries out management responsibilities in accordance with company policies and procedures, applicable laws, Good Manufacturing Practices and Standard Operating Procedures.

Specific Responsibilities & Duties:

• Provide required leadership of the Quality Control function and direct supervision of the Quality Department. Ensures full representation of quality requirements and policy in daily operational decisions and activities.
• Maintain adequacy of equipment, facilities and staff with which to perform Quality Functions. Included are laboratory and testing control, equipment calibration, operation training and evaluation, methods control, records retention and information integrity.
• Maintain adequacy of product and process measurements to provide necessary information for process control according to contract manufacturer requirements, quality standards, product and process specifications, documentations via quality instructions, training, evaluation, etc.
• Maintain accuracy and timeliness of quality information feedback to all units that are responsible for product and process evaluation and quality improvement.
• Effectively utilize the Quality Control workforce, facilities and equipment to meet the organization's goals and objectives.
• Manage personnel including hiring, firing and employee evaluation and performance; disciplinary action and allocation of resources.
• Ensure training programs are established, implemented, and effective for all employees within the department
• Monitor general laboratory operations, product quality and turn-around-time of QC in-process and release testing.
• Investigate and troubleshoots product performance problems. Ensure that all QC operations are in compliance with internal and external standards as well as state and federal regulations.
• Confer with scientists or chemists to conduct analyses, interpret test results and develop nonstandard tests such as methods development, method validation. May use outside laboratories for complementary and/or third-party testing.
• Compile and analyze test information to determine operating efficiency of process or equipment and to diagnose malfunctions. Recommend measures to improve testing procedures, specifications, and use of equipment. Establish or adjust work procedures to meet testing schedules.
• Review and approve all master control record.
• Participate in the investigation process, OOS, change control programs and management review board.
• Maintain the integrity and security of all company information and documents such as formulation files, SOPs, sensitive materials, etc.
• Develop plans, plans of action and budgets for the department needs and prepare reports on department activities.
• Implement Good Laboratory Practices (GLPs) in the Lab; Good Manufacturing Practices (GMPs) and the company's approved Standard Operating Procedures (SOPs).
• Prepare statistical evaluation of quantitative data for executive management.
• Keep, create, manage Masters Samples (Bench Standards), Analysis Certificates, Specifications, Testing Procedures for all Raw materials, Packaging materials, Semi-Finished Products (Bulk) and Finished Products.
• Write and update quality control test procedures.
• Develop new test methods including validation of test methods.
• Maintain cleanliness and good housekeeping in work area.
• Order and maintain supplies necessary for the designated areas.
• Perform other duties assigned by supervisor.

Skill Requirements

Position demands superior oral and written communications skills, Ability to interact with customers, and all local, state, federal, and global regulatory agencies; Good handle of FDA procedures and requirements; Computer literate (excel, word, power point). Word processing experience is required. Experience in a spreadsheet software and database applications is preferred. General computer literacy is prerequisite. Must possess ability to establish and maintain effective working relationships with diplomacy in all facets of the position. Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Qualifications:

B.S. Degree in Sciences, Minimum of 3 years' experience in quality functions, research and development, regulatory affairs. Minimum of 3 years managerial experience. Cosmetic/Drug manufacturing experience.

Work Environment:

• Process Manufacturing
• Laboratory/Office environment
• Noise level is low to moderate
• Proper lighting and ventilation.