Quality Assurance Engineer

The Quality Assurance Engineer will be supporting operational management in their production of safe, quality product. This position is critical in the maintenance of the facility's FDA regulations and multiple quality certifications. We are looking for an individual with strong organizational skills and attention to detail. The QA Engineer will provide expertise in the monitoring and maintenance of the facility preventive control equipment as well as evaluate changes made by the operational teams to equipment and processes. This position will interact with the operation teams daily to provide guidance on quality and to review daily production records.

Primary Responsibilities:

•Champion Safety (training, audits, behavior based safety audits, etc.)

•Ensuring Manufacturing Processes are designed and executed to meet Food, Feed, and API Requirements

•Assists with site CAPA, Deviation, Internal Audit, Supplier Quality, Validation, and Document/Record Management programs

•RCA facilitator

•Review site preventive controls for compliance (food/feed)

•Environmental compliance

•Training and documentation

•Assist with customer, 3rd party, and regulatory audits/inspections activities

•Interact with Plant Engineers, Supervisors, Maintenance, Production Managers, and Unit Managers to facilitate site-wide operating decisions

•Monitor quality equipment performance; provides guidance and documents deviations for failures affecting product quality

•Identifies and follows through with quality improvement projects

•Support ISO 9001 efforts

•Support of capital projects in planning and implementation phases including the Venture Manager role for quality related projects

•Assist with planning / execution of outages

•Assist with investigation and resolution of customer complaints

•Ensure plant processes and facilities are compliant with Food, Feed, API, and drug safety requirements (i.e.: HACCP, FDA, FSSC 22000)

•Ensure plant processes meet cGMP requirements applicable to manufacturing of USP sodium bicarbonate

•Coordinate all Deviations for the regulated plants

•Administrator for management of change (MOC). Approve for quality MOCs initiated in the regulated plants/areas

•Serve as a member of the Food/Feed Safety Teams

•Serve as a member of Product Withdrawal/Recall/Recover Committee

•Serve as a member of the FDA Inspection team

•Responsible for verifying effectiveness of corrective actions

•Leads Bicarb Annual Product Review (APR)

•Leads/Coordinates Annual Management Review (ISO/FSSC 22000)

•Participates in HAACP Review Meetings

•Prepares batch records for product release (API)

•Follows-up on internal/external audit/inspection findings

•Performs internal housekeeping audits

•Perform supplier/transloader audits

•Sampling of raw materials and finished product for testing

•Writing validation protocols and reports

•Oversees execution of validation protocols

Required Skills and Experience:

•Bachelor of Sciences from an accredited four year college/university or

•Bachelor of Arts from an accredited four year college/university with1 year of Quality experience in a manufacturing environment

Preferred Skills and Experience:

•2-3 years of Quality experience in a manufacturing environment

•Operational Knowledge of ICHQ7, FSSC22000, and/or ISO 9001 Quality System Requirements