Job Purpose

• Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations.

• Ensures the accuracy and completeness of batch records.

Performs other duties as assigned or apparent

Essential Duties and Responsibilities:

• Review Batch Records and applicable documentation to ensure complete, thorough and accurate data.

• Responsible for ensuring a high level of employee accountability and performance.

• Maintains quality assurance documentation including shift pass downs.

• Keep QA work station clean and orderly.

• Perform packaging line clearances.

• Pull Retain, Stability, and Lab samples.

• Perform or verify Quality Finished Product Attribute Inspections.

• Perform AQL Calculations.

• Verify component Exhibits

• Verify all documents are present within the batch record.

• Support validation and manufacturing studies, including special sampling and testing.

• Communicate with Management any quality issues identified with product

• Supplemental Functions:

• Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.

• Assist with development of solutions for chronic problems within quality assurance

• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.

• Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.

• Assist in other activities (as needed) for Quality Assurance management.

Job Specifications and Qualifications:

Skills:

• Detail oriented.
• Technical writing skills required.
• Good written, oral and comprehensive communication skills.
• Operating computer and relevant software;.
• Must be proficient in MS Word, Excel, and PowerPoint;

Abilities:

• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication; and provides participation, learning, feedback and recognition.
• The ability to effectively manage one's self, demonstrates integrity, be productive under pressure, and achieve development goals.
• Ability to handle contending priorities and managing partner expectations
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• Assist in other activities (as needed) for Quality Operations management.
• Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law.
• Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Requirements

Education/Experience:

• Minimum of High School Diploma or GED required.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility.