• 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 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 principles of corrective/preventive action to situations and incidents.

• Computer literate in word processing and spread sheet functions.
• Attention to detail and ability to critically examine a process/procedure is extremely important.
• Knowledge of Statistical Process control and Quality Engineering would be helpful.
• Must be able to work in an environment of rapidly changing priorities and levels of intensity.

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls and talk and hear.
• The employee frequently is required to stand and sit.
• The employee is also required to walk, reach with hands and arms, and taste or smell. Specific vision abilities required by this job include close vision and color vision.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• The employee must occasionally lift and/or move up to 25 pounds.

• The noise level in the work environment is usually low to moderate. Occasionally, the employee may be exposed to loud machine noise.
• Other duties may be assigned by management.

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