Visual Inspection GMP, 2nd Shift

Onsite in Billerica, MA, Monday-Thursday 4PM -2:30AM with OT on Friday. 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.