Quality Assurance Specialist - Forsyth, MO

Location: Forsyth

** 103915 *
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* Job Title:

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* Quality Assurance Specialist - Forsyth, MO

** Department/Function:*
* Operations:
Manufacturing, Production, Maintenance, Utilities

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* Job Description:

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* ** Quality Assurance Specialist - Forsyth, MO*
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* SUMMARY:

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* 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.

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* ESSENTIAL DUTIES AND RESPONSIBILITIES:

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* + 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 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.

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

+ Carryout 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.

+ Provides support or performs laboratory analysis on validation or verification samples as required.

+ Reviews and compiles data obtained for validation, verification, and investigation activities.

+ Performs verification activities to confirm the success of implemented processes or action items.

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

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

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

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

+ Manages equipment maintenance and calibration program, coordinating and ensuring completion of relevant documentation (prior to use where applicable).

+ 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 / 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 on the purity, quality and…