Manufacturing Associate

Full Time
Fort Worth, TX 76107
Posted
Job description
Role Overview:
The Manufacturing Associate will perform all activities involved in the aseptic
processing of a biologic product, under the direct supervision of the
Manufacturing Supervisor. This position will support the Manufacturing
department by performing tasks that will assure the safe and timely processing
of the product, working in a classified GMP environment.
Responsibilities:
  • Prepare product, according to production planning and GMP regulations.
Initiate, create, and review batch records and labels and perform regular
checks on the process, following batch records, in order to product to
according to GMPs (10%)
  • Responsible for manufacturing a cell-based product according to
established Master Batch Records and Operating Procedures (10 %)
  • Responsible for the preparation and in-process testing of all media,
reagents, substrates for testing, and sanitizing agents used in
manufacturing areas (10 %)
  • Responsible for proper operation of all clean room equipment. Assist
with maintenance and equipment validation as needed (10 %)
  • Prepare, author, and execute procedural SOP'S, specifications, protocols,
data analyses, and technical reports, as needed. (10 %)
  • Responsible for assuring Standard Operating Procedures and Batch
Records are complete and compliant in alignment with processing (10 %)
  • Responsible for maintaining all required records to established
guidelines for production procedures, the GMPs, and safety. (10 %)
  • Responsible for adherence to all Operating Procedures, protocols,
policies, regulatory requirements, the GMPs, and the safety guidelines.
(15 %)
  • Responsible for conducting on-the-job training for incoming
Manufacturing Operators (5 %)
  • Regularly execute performance checks on the assigned production
apparatus in order to signal defects as soon as possible. Participate in
environmental monitoring and process validation, when applicable (5 %)
  • Perform other duties as required (5 %)
Location: Fort Worth, Texas
Shift Available: 1st Shift Monday - Friday, 1st Shift Wednesday - Sunday, 2nd Shift Monday - Friday

Education: High school diploma or GED required. Bachelor of Science in Biology
or other Life Science focus is preferred.
Licenses/ Certifications: None
Experience: 2-5 years experience (cell science experience is preferred)
Competences:
GMP experience is required
Regulated industry experience is required
Physical Demands: None required
Travel Requirements: No travel required
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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