Quality Validations Manager

Job Description

Quality Validations Manager

• Kennesaw, GA

NATURE & SCOPE

• The Quality Systems and Validations Manager will lead the oversight, maintenance, and continuous improvement of the Quality Systems and Validation programs. Core responsibilities are as follows:

• Oversee, plan, ensure execution, and review Food Safety Programs including EMP, HACCP Plans, Pest Control, Equipment Verification and Calibrations, Food Fraud, and Food Defence programs

• Collect, interpret, and visualize data for Management Reviews including identifying and documenting trends pertaining to relevant systems

• Document and assist as needed in execution of process and equipment validations, including IQOQPQ validations for regional sites

MAJOR ACCOUNTABILITIES

The Quality and Systems Validations Manager will be knowledgeable in FDA regulations and associated certifications relevant to the site. Specific responsibilities include but are not limited to the following:

• Act as the Food Safety Team Leader and ensure compliance and regular reviews are conducted on the Food Safety, Food Fraud, and Food Defense Plans

• Create and assist in the establishment of calibration protocols and maintenance records in accordance with cGMP, cGLP and/or regulatory requirements.

• Assist in the review, trending, and management of equipment, calibration, and maintenance records.

• Create, review, and approve as needed with development and execution of validation and qualification of methods, processes, and equipment; Perform validations as required.

• Conduct CAPAs investigations for system-related NC's (i.e pest control or EMP failures)

• Gather data and conduct trending evaluations relevant KPI's to determine the health of the QMS system and assist in the reporting for Management Reviews. Ensure all data is gathered in preparation for Management Review.

• Provide guidance and train others on Quality System procedures.

• Perform IQ OQ PQs as required for production equipment.

• May be called upon to review data, protocols, reports, technical specifications, and spreadsheet validations.

• Oversight of the Validation Master Summary (VMS), adding new activities, ensuring existing activities are up to date, and obsoleting old activities.

• Evaluate temperature mapping of the warehouse/production facilities and prepare reports.

• Provide quality review and investigation on OOS stability samples to provide to Product Development.

• May serve on project teams.

• Performs other duties as assigned.

Education

• Minimum

• Bachelors Degree in Engineering, Chemistry, or equivalent

Experience

• Minimum

• 1+ years quality experience in an FDA regulated facility; 1+ years CAPA/NC related experience

• Preferred

• Experience in Federal and State Food Safety Regulations including HACCP and GFSI

Specific Skills & Abilities

• Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment

• Strong leadership skills

• Strong knowledge of current quality systems requirements and implementation techniques.

• Superior communication and analytical skills, plus demonstrated skills to handle a variety of assignments simultaneously.

• Customer-advocate to ensure on time task completion.

• Requires excellent written and verbal communications.

• Must have the ability to assess situations and develop solutions

• Must have excellent attention to detail

• Must have the ability to adjust to changing work demands and priorities in a fast paced environment

• Experience with Microsoft Office products with an emphasis on Excel

• Strong analytical experience

• Ability to learn new technologies quickly

• Results driven, strong work ethic

• Strong organizational and time management skills

• Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

• Must be able to walk, bend, kneel, stoop, climb, reach and grasp for varying periods of time

• Ability to work flexible schedules including nights and weekends

• Fluent in English required, bilingual (Spanish) preferred

• Must possess a valid US driver's license

Excited about this role but don't meet every requirement listed? Studies show that often applicants will self-select out if they don't check every box. We encourage you to apply anyway. You may be just the right candidate for this role or another one of our openings.

ADM requires the successful completion of a background check.

REF:86983BR