GMP Manufacturing Technician
- Posted: 22 days ago
Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasizes our commitment to efficiently advancing client programs through the clinic to commercialization. We share a common goal to bring real value to people, healthcare professionals and health businesses around the world. Driven by our commitment to improve our health, we deliver services that offer hope – and a better, safer and healthier life for everyone.
Under the direction of scientific staff, independently perform dispensing, manufacturing, and packaging operations in conjunction with approved Batch Records. Provide routine trouble-shooting and cleaning of complex equipment. This is an Entry Level opportunity-We are willing to train hard working, dedicated individuals!
This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.
1. Under the direction of scientific staff, assist with the manufacturing, dispensing and packaging of toxicology and Sterile GMP clinical supplies for Phase I clinical studies using a variety of manufacturing processes and equipment
2. Complete Manufacturing Batch Records in accordance with GMP documentation requirements
3. Provide GMP cleaning of equipment, instrumentation, and clean rooms
4. Perform various activities in a clean room environment
5. Able to be gown qualified in a ISO 5 and ISO 7 environment, and pass a respirator fit test
6. Maintain data in laboratory notebooks as needed
7. Adhere to all standard operating procedures
8. 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and Experience:
High School diploma required; 2-year degree or formal technical training a plus
Required Knowledge and Skills
• Minimum of 1 year experience in a cGMP sterile fill finish environment preferred
• Strong mechanical and math skills required
• Ability to communicate well in both oral and written form
• Self-starter with the ability to work in a team environment as well as independently while handling multiple projects
• Willingness to learn and expand their knowledge and technical expertise in a motivated and fast paced environment.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in a manufacturing laboratory setting, use pharmaceutical manufacturing equipment and stamina to stand for extended periods of time; exerting up to 50 pounds of force occasionally and/or up to 20 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Work is performed in a manufacturing laboratory setting. Work can be subject to chemicals, fumes, gasses, noxious odors and related items in a lab setting.
Pace Life Sciences, LLC is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, and individuals with disabilities, sexual orientation, or gender identity.
Full-time day shift working Monday through Friday. Evening and occasional weekends hours may be required based on manufacturing schedule.
Pace Analytical Services LLC
AddressSan Diego, CA
ManufacturingView all jobs at Pace Analytical Services LLC
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