Nature & Scope 

The Quality Assurance Specialist provides direct Quality support to Production. The Quality Assurance Specialist, with guidance from the Quality Assurance Supervisor, ensures product / process quality and performs activities to review batch record documentation, facilitate the release of product to the marketplace, and ensures proper control of material through maintenance of the Ross system. The Quality Assurance Specialist also performs process document / log book audits for accuracy and completeness and works closely with Planning, Materials Management, and Production in a team environment to ensure timely review and documentation is done right the first time. He or she provides generalist quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, and effective investigation of deviations. Additionally, the Quality Assurance Specialist performs routine GMP walk through inspections of the shop floor to ensure compliance with cGMPs and regulatory requirements.

Major Accountabilities 

The Quality Assurance Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas are in compliance, and will train on and gain competency in activities to facilitate release of product.  Specific responsibilities include but are not limited to the following:

• Perform document control activities including, but not limited, issuing master manufacturing records, review and approving batch records and work instructions, ensuring logs and records are appropriately completed and maintained, and   scanning, filing and maintaining all records as required.

• Review lab analysis reports for the approval of raw materials, in process products, and finished goods, alerting the Quality department of any deviations from specifications.

• Collaborates with Planning, Operations and Technology organizations to ensure batches and raw materials are ready for release by appropriate due dates.

• Assists in sending samples to the laboratory or other testing facilities.

• Completes required Ross transactions to release raw materials, works in process, and finished goods in Ross.

• Completes, reviews and sends release records to Quality Assurance or other interested parties.

• Performs 100% audit of process documents / log books to ensure completeness and accuracy.

• Prioritizes document review to ensure alignment with product release due dates.

• Maintains any tracking databases and logs associated with review, release and metrics.

• Provides coaching and mentoring of manufacturing supervisors and operators completing documentation.

• Coordinates with Production to discuss, resolve, and eliminate documentation observations.

• Performs cGMP walk through inspections to ensure compliance with cGMPs and regulatory requirements.

• Ensures proper identification of release status and control of materials through maintenance of quarantines in Ross and through physical tagging of material as required.

• Assists with training of incoming personnel and ensures compliance with departmental procedures.

• Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans.

• Collaborates with team members to investigate deviations on production floor during shift.

• Works with necessary groups to resolve outstanding issues with process documents / log books, cGMP walk through inspection observations and quarantine, management.

• Assist Production, Maintenance, Quality and engineering to develop, write, review and train on Standard Operating Procedures and Policies, Work Instructions, and Forms.

• Other duties as assigned.

Job Profile

Education 

• Minimum – High School Diploma.

Experience 

• Preferred two years as a quality inspector or technician in a manufacturing environment

• Experience working in an FDA regulated environment

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

• Experience with food safety and defense programs

Specific skills 

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

• Strong leadership skills

• Must have the ability to assess situation and develop a solution

• Must have good attention to detail

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

• Effective communication and report writing skills; legible handwriting required

• 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 lift up to 75 pounds

• Ability to perform a standing job for a full shift

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

• Ability to differentiate subtle variances in color

• Ability to drive a forklift

• Ability to wear a respirator and hearing protection

• Ability to work flexible schedules including nights and weekends

• Fluent in English required, bilingual (Spanish) preferred

• Must possess a valid US driver’s license.