Quality Assurance Specialist - Forsyth, MO

Quality Assurance Specialist

Attention military affiliated job seekers - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, transitioning military, National Guard and Reserve members, military spouses, wounded warriors, and their caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

The Quality Assurance Specialist provides direct support to the success of Quality Systems. The Quality Assurance Specialist, with guidance from the Director of Quality Assurance, performs duties required to maintain the Quality Systems, including periodic verifications of systems and equipment, coordination and completion of calibrations and maintenance/installation of equipment, assisting with and performing validations, completion of auxiliary quality programs, and assisting in investigations.

The Quality Assurance Specialist will perform finished good material review (batch record review) and approval of batch paperwork. They will work closely with the Document Control, Quality Control, and Production in a team environment to ensure timely completion and documentation of associated tasks. They provide 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 will provide direct support to the investigation, verification, and implementation of non-conformances and deviations.

Essential duties and responsibilities include:

• Perform document control activities including but not limited to reviewing and approving certificates of analysis and batch folders, filing and maintaining all records as required.
• Alerting the Quality department of any deviations from specifications and assisting with investigations by collecting additional data or samples as required.
• Collaborating with Planning, Operations and Technology organizations to ensure batches and raw materials are ready for release by appropriate due dates.
• Carrying out validation or verification procedures to ensure compliance of systems.
• Collecting various types of samples to send to the laboratory or other testing facilities for investigations, validations, or trending purposes.
• Providing support or performing laboratory analysis on validation or verification samples as required.
• Reviewing and compiling data obtained for validation, verification, and investigation activities.
• Performing verification activities to confirm the success of implemented processes or action items.
• Completing, reviewing and sending release records to Quality Assurance or other interested parties.
• Prioritizing document review to ensure alignment with product release due dates.
• Providing coaching and mentoring of manufacturing supervisors and operators completing documentation.
• Coordinating with Production to discuss, resolve, and eliminate documentation observations.
• Managing equipment maintenance and calibration program, coordinating and ensuring completion of relevant documentation (prior to use where applicable).
• Collaborating with team members in the identification and implementation of continuous improvement initiatives and action plans.
• Collaborating with team members to investigate deviations on production floor during shift.
• Working with necessary groups to resolve outstanding issues with process documents / logbooks, cGMP walk through inspection observations and quarantine, management.
• Assisting Production, Maintenance, Quality and engineering to develop, write, review and train on Standard Operating Procedures and Policies, Work Instructions, and Forms.
• Performing or managing Quality system verifications, such as periodic adequate lighting verification, pressure differential verification, etc.
• Other duties as assigned. Responsible for the creation and maintenance of policies and procedures that impact on the purity, quality and composition of products manufactured by Deerland.

Equipment used includes computer systems, hardness tester, disintegration apparatus, friability tester, balances, office equipment, and others as needs require. Working knowledge of all equipment is essential.