Visual Inspection GMP

Responsible for the labeling and packaging of pharmaceuticals for world wide distribution. The kit packaging operation is largely a manual operation, with some labeling operations performed by the use of automated labeling machines. Kit Packaging personnel primarily perform a manual visual inspection of filled vials. Must follow SOPs and the ability to follow manufacturing batch records. Understands and complies with cGMP work environment standards and support a strong safety culture. Ability to work in a fast paced work environment while maintaining attention to detail. Ability to work in a team oriented work environment. Willing to work overtime when required.

Essential Functions

• Demonstrate the ability to conduct visual inspection per established qualification criteria.
• Demonstrates practical knowledge of subjects such as area clearances, product accountability, label control, product segregation and control, operator/check by and other basic skills required to work in a pharmaceutical environment.
• Understands and follows SOPs. Fills out standardized forms correctly. Instructs other team members on basic procedures.
• Demonstrates fundamental writing skills, such as proper spelling, appropriate grammar and punctuation.
• Communicates effectively with team members and other internal groups. Demonstrates the ability to listen.
• Exercises judgment to make routine decisions within established limits. Consults with team members or team leader as necessary.
• Understands the role of a team member and how he/she impacts team objectives. Actively participates in team discussions and decision making. Supports other team members.
• Demonstrates knowledge of applicable industrial safety as outlined in the site safety manual; including areas such as material handling, chemical compatibility, equipment use and inspection.
• Demonstrates knowledge of basic math and science skills as they relate to a manufacturing and labeling environment.

Essential Functions

• Understands the concept of continuous improvement. Actively participates in improvement projects. Performs duties in a way that minimizes waste and maximizes efficiency. Maintains awareness of and continues to assess self against pre-established personal and team objectives. Is aware of how these objectives influence overall business success.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.

Typical Minimum Skills and Experience and Education

• High School Diploma with 0 3 years experience in manufacturing operations (Pharmaceutical environment preferred) or Associates Degree. A combination of education, training and experience may be considered in lieu of above stated requirements.

Other Requirements

• Previous experience working in a team environment. Ability to react to short notice production schedule changes.
• Demonstrated ability to communicate information effectively to a variety of individuals in a manner that promotes productive relationships.
• Ability to work in accordance with cGMP guidelines.
• Knowledge of pharmaceutical processing and manufacturing, including issues pertaining to cGMP, and specialized processing equipment.
• Sufficient working knowledge of computer systems and platforms.