QO Secondary Packaging Tier I

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

• Affords assistance in monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
• Affords assistance in developing solutions for chronic problems within quality assurance.
• Communicates quality-related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
• Assists 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; proficiency 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.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• 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.
• Education/Experience:
• Minimum of High School Diploma or GED required.
• Working Conditions / Physical Requirements:
• This position requires bending, typing, lifting (up to 25 lbs.), standing, sitting and walking throughout the facility.