POSITION SUMMARY:  

The QA Specialist is responsible for establishing and managing the quality improvement efforts for the Quality Assurance department as it pertains to site manufacturing and packaging processes.  This includes providing leadership, guidance, and management of the activities associated with site investigations.  They will work with Technical, Operational, and Quality personnel and evaluate processes to perform failure mode analysis and identify appropriate corrective and preventive actions.  The QA Specialist must work with all site business units, Quality Operations, Manufacturing, and Customers under limited supervision.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Writes clear and concise investigations, technical reports, process descriptions, and standard operating procedures

• Articulates important issues and solutions to both technical and non-technical peers and to department management.
• Develops strong Subject Matter Expertise in relevant areas of manufacturing and packaging to support both investigations and evaluation of existing processes for quality improvement.
• Keeps abreast of current developments and trends in areas of expertise.  Assimilate and apply new job-related information that may vary in complexity within a reasonable period of time. 
• Reviews and approves production documents, with a focus on ensuring that they are designed to yield a quality outcome
• Manages, updates, and trains on departmental procedures. 
• Lead the CAPA process for internal and customer complaints, CAPA meetings, issue CAPA numbers and update the CAPA log.
• Maintain and own the document control process and issuing SOP’s and Document change control.
• Do final product release for finish ingredients (FG) and issue applicable documents to customers per their requirements.
• Support Quality Director during regulatory, customer and ISO audits.
• Assist Regulatory specialist for consumer complaint investigations as needed.

REQUIRED EDUCATION/EXPERIENCE:

• Minimum of B.S. degree in Chemical Engineering or Chemistry. Other bachelor degrees may be acceptable when supplemented with Quality assurance experience in a manufacturing in FDA regulated environment.       
• Minimum 5 years of experience in a quality assurance role in a manufacturing/packaging environment.

ADDITIONAL ELIGIBLITY QUALIFICATION:

• Ability to analyze data and translate it into meaningful conclusions
• Clear and concise technical writing skills
• Good knowledge of word, excel, power point, charts and graphs for data trending.
• Effective active listening Skills.
• Fosters open communication with individuals at all levels of the organization.
• Assimilates new knowledge skills, and job-related information that may vary in complexity, and applies them to work assignments in a timely manner.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law:

The working environment includes both office and plant floor settings. Exposure to industrial noise, forklift traffic, noise, wet floors, odors, fumes, moving mechanical parts, and temperature fluctuations and extremes in operating areas of the plant. Specified PPE required in operational areas.

• Possible exposure to airborne dust and chemicals associated with a micro laboratory and cosmetic processing facility.
• Possible exposure to pathogens while handling test plates and culturing microorganisms.
• Moderate safety risks associated with a light industrial environment.
• Moderate safety risks associated with steam sterilization operations.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law:

• Walking and some climbing of stairs & walkways required.
• Must be able to lift, bend, stoop, crouch, reach and climb.
• Repetitive motion of the wrists, hands, and/or fingers.
• Ability to lift and carry up to 30 lbs. occasionally.
• Sitting for extended periods of time working in front of a computer screen.