Manufacturing Associate I – 2nd Shift - #7947340

Repligen Corporation


Date: May 8, 2021
City: Marlborough, MA
Contract type: Full time
Repligen Corporation
Overview:

The Manufacturing Associate will perform various activities in the production of tangential flow filtration cassettes such as single-use and reusable device assembly, die cutting, component encapsulation, inspection and final packaging, etc. The successful candidate will play a key role in ensuring that the department's production and quality goals are met following Repligen's ISO 9001 Quality Management System in support of the manufacturing process. Must be able to follow oral and written instructions accurately (English), learn complex tasks quickly, and complete tasks in a timely manner. Good hand-eye coordination, manual dexterity, attention to detail, and the ability to work in a team environment are essential. Many functions require standing for long periods of time and some lifting up to 50 lbs. The ability to successfully cross train into other areas/functions may be required based on the changing needs of the department. Candidates must be flexible to work overtime (including weekends) as required. Training will be on the first shift for approximately 6-8 weeks prior to transitioning to second shift. 1st Shift: 6:30 a.m. - 3:00 p.m; 2nd Shift: 3:00 p.m. – 11:30 p.m
Responsibilities:


Responsibilities may include the following:




  • Die cutting cassette components using process equipment and tooling, following SOPs and other documentation and training. Visual inspection of materials and cut components to internal quality standards. Use of correct tooling, ensuring quality and quantity are produced. Ensure tooling is clean, functional, and operational. Correct documentation of batch records and other documentation as required.


  • Encapsulation of components using process equipment to complete specific operations following SOPs, other documentation and training. Mixing of components and completion of process documentation is required. Must be able to work with chemicals.


  • Assembly of single-use/reusable cassette devices or assembly of hardware following SOPs and training, performing 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. Perform data entry as required.


  • Perform final inspection and packaging of cassette products. Use of production equipment and labeling equipment required. Ensure all process documentation is completed accurately. Perform data entry as required.


Qualifications:

Qualifications:

  • Requires HS level education (Minimum)



  • Knowledge of GMP/ISO/document-controlled processes preferred


  • Must be able to write clearly on data sheets, logs, training records and other documentation


  • 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


  • Ability to work effectively with hand tools


  • Strong technical knowledge and problem-solving skills preferred


  • Must be resourceful and self-motivated


  • Ability to work efficiently in an ISO-9001 quality system with appropriate attention to detail in the performance of controlled procedures


  • Must be able to stand for long periods of time and be able to lift up to 50 pounds.




  • Must be computer literate and familiar with MS Office


  • Candidates must be willing and able to learn new manufacturing processes as the company grows, and to work overtime (including weekends) as required.

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