Quality Assurance Specialist - Forsyth, MO

Archer Daniels Midland•Forsyth, MO

About The Position

The Quality Assurance Specialist provides direct support for the success and maintenance of Quality Systems, with guidance from the Director of Quality Assurance. The role performs periodic system and equipment verifications; coordinates calibrations and equipment maintenance or installation; assists with and performs validations; completes auxiliary quality programs; and supports investigations. The specialist reviews finished-good materials and batch records and approves batch paperwork. Working closely with Document Control, Quality Control, Production, and other groups, the specialist helps ensure associated tasks are completed and documented on time and provides quality support on the production floor, including oversight of cGMP adherence, production documentation, and deviation investigations. The specialist develops knowledge of federal and other regulatory requirements and cGMPs and builds competency in activities that facilitate product release. The position also supports the investigation, verification, and implementation of non-conformances and deviations, and is responsible for creating and maintaining policies and procedures that affect the purity, quality, and composition of products manufactured by Deerland. Work involves computer systems, laboratory and testing equipment, and office equipment. The environment is usually low to moderate in noise, with occasional exposure to loud machine noise.

Requirements

Bachelor’s degree from a four-year college or university and one year of related industry experience and/or training, or an associate degree and five years of related industry experience.
Valid driver’s license.
Ability to read and interpret scientific and technical journals and legal documents, and respond to regulatory agencies and customers when required.
Excellent verbal and written communication skills.
Ability to calculate figures and amounts such as proportions, percentages, and statistical data.
Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.
Ability to assess policies, procedures, and processes for compliance with applicable standards and apply corrective and preventive action principles.
Computer literacy in word processing and spreadsheet functions.
Attention to detail and ability to critically examine processes and procedures.
Ability to work amid rapidly changing priorities and varying levels of intensity.
Working knowledge of relevant equipment is essential.

Nice To Haves

Knowledge of Statistical Process Control and Quality Engineering.

Responsibilities

Perform document control activities, including reviewing and approving certificates of analysis and batch folders, and filing and maintaining records.
Alert the Quality department to deviations from specifications and assist investigations by collecting additional data or samples.
Collaborate with Planning, Operations, and Technology to ensure batches and raw materials are ready for release by appropriate due dates.
Carry out validation or verification procedures to ensure systems comply with requirements.
Collect samples for laboratory or other testing facilities for investigations, validations, or trending.
Support or perform laboratory analysis on validation or verification samples as required.
Review and compile data from validation, verification, and investigation activities.
Perform verification activities to confirm the success of implemented processes or action items.
Complete, review, and send release records to Quality Assurance or other interested parties.
Prioritize document review to align with product release due dates.
Coach and mentor manufacturing supervisors and operators on documentation completion.
Coordinate with Production to discuss, resolve, and eliminate documentation observations.
Manage equipment maintenance and calibration programs, coordinating their completion and associated documentation, including documentation required before use where applicable.
Collaborate with team members to identify and implement continuous improvement initiatives and action plans.
Work with team members to investigate production-floor deviations during shifts.
Work with relevant groups to resolve outstanding process-document and logbook issues, cGMP walkthrough inspection observations, and quarantine management matters.
Assist Production, Maintenance, Quality, and Engineering in developing, writing, reviewing, and training on standard operating procedures, policies, work instructions, and forms.
Perform or manage Quality System verifications, such as periodic adequate-lighting and pressure-differential verifications.
Create and maintain policies and procedures affecting the purity, quality, and composition of products manufactured by Deerland.
Perform other duties as assigned.

Benefits

Medical and prescription coverage, dental insurance, and vision insurance.
On-site wellness center access or gym reimbursement, as applicable.
Flexible spending accounts and health savings account.
401(k) with matching contributions and a cash balance plan.
Discounted employee stock purchasing program.
Life insurance and disability coverage.
Workers’ compensation, legal assistance, and identity theft protection.
Employee Assistance Program, Employee Resource Groups, and colleague giving programs.
Paid time off, including paid holidays.
Adoption assistance and paid maternity and parental leave.
Tuition assistance.
Company-sponsored training and development resources, including LinkedIn Learning, language training, and mentoring programs.