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QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

+ Under general supervision, perform operations in the Manufacturing area.

+ Operations will be performed according to Standard Operating Procedures (SOPs).

+ Perform in-process sampling of drug substance applying analytical equipment.

+ Perform hands-on operations that include inspecting and installing single use components, chromatography operations, UF/DF operations, sample analysis, drug substance fill operations and breaking down vessels.

+ Perform technical writing to draft and revise documents such as Manufacturing Procedures, Deviations, Safety Reporting, and Equipment logs.

+ Conduct basic troubleshooting and assist in the review of documentation for assigned functions.

+ Opportunities to participate in cross-functional teams to expand technical background in the bio-technologies industry.

+ Identify, recommend and implement improvements related to CAPAs or Continuous Improvement initiatives.

+ Organizing and maintaining material inventory in the manufacturing space.

+ Collaborating with multiple computer systems (Delta V/EBRs) simultaneously to complete operations or troubleshoot issues on the floor.

+ Assisting in the review of documentation for assigned functions (equipment logs, batch records)

+ Champion Lean Transformation and OE initiatives; facilitate the drive towards continuous improvement in all Manufacturing areas.

+ Operating liquid chromatography skids/columns, TFF skids and membranes and other associated equipment to purify, formulate and fill drug substance products.

Qualifications:

+ Bachelor of Science ((either biology/ engineering) or High school with 1 year work experience in Biotech manufacturing.

+ Systems MS office suite knowledge

+ Good written communication

+ Understands the principles of safety culture and working effectively on a team, lab exposure and worked in an environment where safety is top priority.

+ Day Shift Schedule as follows: 6:45 AM - 7:00 PM.

+ Will be on Swing Shift - Week 1 is 5 working days Week 2 is 2 working days.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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