The QC Manufacturing Associate I will be reporting to the Quality Control Manager.  This role will perform various activities in the Testing of tangential flow filtration cassettes. The ability to successfully cross-train into other areas/functions may be required based on the changing needs of the department. The successful candidate will play a key role in ensuring that the department's production and quality goals are met. Applicants must have strong technical knowledge and problem-solving skills. The candidate must be able to follow oral and written instructions accurately (English), learn complex tasks quickly, and complete tasks in a timely manner. Many functions require standing for long periods of time and some frequent lifting up to 50 lbs. The successful candidate will actively follow Repligen ISO 9001 Quality Management System in support of the manufacturing processes and final product testing. Experience working in a classified cleanroom, and knowledge of GMP/ISO/document-controlled processes would be beneficial. Attention to detail, and the ability to work in a team environment are essential. Most operations require good hand-eye coordination and manual dexterity. The candidate must be computer literate with some MS Office experience.

• QC testing of cassette filters and Membrane MWCO. Following SOPs and training, testing cassettes and membrane ensuring quality and quantity are produced. This includes Ability to read and follow test and process specifications. Understand RPS system and participate in Tiered Boards, GEMBA, and 5S.
• The operator will be required to properly use process equipment and follow the job testing assignment schedule. The operator must also be able to understand specific operations and follow SOPs, other documentation and training. Mixing of solution/test markers and completion of Process documentation is required. Must be able to work with chemicals.
• Following SOPs and training, perform assembly and visual inspection of product. Ability to read and follow drawings/ Bill of Materials to complete components. Work in a controlled environment will be required for certain aspects of these operations. Ensure all process documentation is completed correctly and concisely. May perform some data entry as required.
• Participate in use of Velocity to report hazard IDs and near misses, suggest remedial action. Ability to cross-train within QC department.

• Other Functions:
  • Maintain cleanliness of workspace and tooling.
  • Interface with QA representative and production personnel to maintain flow of product, as well as to identify non-conforming products
  • Meet target of intermediate and long-term goals established by management. Long term goals will be established annually and followed by both the employee and management throughout the year.
  • Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner.
  • Candidates must be willing and able to learn new manufacturing processes as the company grows and also to work overtime as needed (including weekends).

• High School Degree required.
• 2-3 years of relevant experience required.
• Must be computer literate, preferably with MS Office and SAP
• Ability to work independently once training has been completed.
• High attention to detail applied to all aspects of daily activities.
• Excellent organizational and communications skills.
• Must be resourceful and self-motivated in a fast paced environment.
• Ability to work efficiently in an ISO-9001 quality system with appropriate attention to detail in the performance of controlled procedures.
• Ability to work overtime, including weekends.
• Must be able to lift up to 50 lbs. routinely.