I. PRIMARY FUNCTION:
Responsible for hands-on GMP manufacturing of Abyrx’s medical products. Responsibilities include operating machinery to produce product per the procedures, perform in-process inspection, as well as maintaining accurate records/documentation related to batch record keeping.
II. DUTIES AND RESPONSIBILITIES:
Performing in-process inspection, identify defects, segregate and document the results
Operating equipment to produce product per the procedures and training provided
Manufacturing product with the highest quality and throughput
Maintaining accurate records/documentation, computer entry related to quality, work in progress, test results, and special instructions
Reading, understanding and strictly following standard work instructions
Performing minor set-ups and adjustments while maintaining tolerance in accordance with work instructions
Accurately filling out records/documentation related to work in progress and labor reporting (e.g. timecards)
Maintaining clean room integrity by wearing proper attire including hair net, gloves, safety glasses, ear protection, lab coat, and a beard cover if applicable.
Adhering to:
FDA regulations
Clean room environment practices and procedures
Good Manufacturing Practices (GMP)
General safety and manufacturing procedures
Company practices and policies
III. SUPERVISORY/MANAGEMENT RESPONSIBILITIES (IF APPLICABLE):
N/A
IV. WORKING RELATIONSHIPS
Good teaming skills and ability to work closely with others
Be flexible, open to change and cross-train
Interacts with R&D, Quality and other employees within ABYRX.
V. EDUCATION, EXPERIENCE AND OTHER REQUIREMENTS:
Ability to:
Read, comprehend and communicate in English
Stand or sit for long periods of time and perform repetitive handling of product(s)
Work a reasonable amount of overtime when needed
Work independently and within a functional team