QO Secondary Packaging Tier I

 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. 

 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.