QO Secondary Packaging Tier I

Description 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.