Visual Inspection GMP

2 months ago

billerica, United States Randstad Full time

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 SOP’s 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 SOP’s. 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.

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