Quality Assurance Specialist - Forsyth, MO

Job Description

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, including 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.

• 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 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.
• Collaborate with Planning, Operations and Technology organizations to ensure batches and raw materials are ready for release by appropriate due dates.
• Carry out validation or verification procedures to ensure compliance of systems.
• Collect various types of samples to send to the laboratory or other testing facilities for investigations, validations, or trending purposes.
• Provide support or perform laboratory analysis on validation or verification samples as required.
• Review and compile data obtained for 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 ensure alignment with product release due dates.
• Provide coaching and mentoring of manufacturing supervisors and operators completing documentation.
• Coordinate with Production to discuss, resolve, and eliminate documentation observations.
• Manage equipment maintenance and calibration program, coordinating and ensuring completion of relevant documentation (prior to use where applicable).
• Collaborate with team members in the identification and implementation of continuous improvement initiatives and action plans.
• Collaborate with team members to investigate deviations on production floor during shift.
• Work with necessary groups to resolve outstanding issues with process documents/logbooks, 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.
• Perform or manage 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 the purity, quality and composition of products manufactured by Deerland.

• Computer systems, hardness tester, disintegration apparatus, friability tester, balances, office equipment, and others as needs require.
• Working knowledge of all equipment is essential.

• Appropriate Bachelor's degree (B.A.) from four-year college or university; and 1-year related industry experience and/or training; or an Associate’s degree and 5 years of related industry experience.
• Must have a valid Driver’s License.

• Ability to read and interpret scientific and technical journals and legal documents.
• Ability to respond to regulatory agencies and customers when required to do so.
• Must possess excellent communications skills, both verbal and written.

• Ability to calculate figures and amounts such as proportions, percentages, and statistical data.

• Ability to define problems, collect and analyze data, establish facts to draw valid conclusions.
• Must be able to reasonably assess policies, procedures, and processes for compliance to various standards.
• Must be able to apply…