SUMMARY

Responsible for dispensing, manufacturing, and packaging operations in a Current Good Manufacturing Practice (cGMP) environment while maintaining accurate batch records and following in accordance with all Standard Operating Procedures (SOPs). General, routine cleaning and maintenance of all equipment and instrumentation.

 

ESSENTIAL FUNCTIONS Assist dispensing, manufacturing, and packaging of GMP clinical materials for clinical studies while wearing appropriate PPE as required. Complete manufacturing batch records in accordance with GMP documentation requirements; lead the manufacturing operations and following of batch record instructions. Perform various activities in a clean room or sterile environment, as well as assist with cleaning of equipment, instrumentation and rooms. Maintain accurate records and follow batch record instructions to support data integrity. Adhere to all SOPs, cGMP's and applicable FDA regulations. Lead manufacturing operations and adherence to batch record instructions. Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment. QUALIFICATIONS Education and Experience High School Diploma/GED required, some college or technical training preferred. ne to three (1-3) years of comparable manufacturing operations or technical experience; OR an equivalent combination of education, training and experience.   Required Knowledge and Skills Required Knowledge Working knowledge of manufacturing equipment and instrumentation. Intermediate knowledge of principles, practices, and techniques to troubleshoot and solve problems. Intermediate understanding of applicable area laws, codes and regulations. Intermediate understanding of batch records and laboratory notebooks. Principles and practices to serving as an effective project team member. Effective methods to communicate with staff, coworkers, and customers to ensure safe, effective and appropriate operations. Correct business English, including spelling, grammar, and punctuation Required Skills Ability to follow a standard operating procedure. Mechanical and math skills required. Operating in both a team and individual contributor environment. Intermediate understanding and following applicable laws, codes and regulations. Using tact, discretion, and prudence in working with those contacted in the course of work. Contributing effectively and taking initiative in accomplishing team or work unit goals, objectives, and activities. Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of work. PHYSICAL/MENTAL REQUIREMENTS

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 50 pounds of force occasionally and/or up to 25 pounds of force frequently to lift, carry, push, pull or move objects.