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.Essential Duties and Responsibilities
include the following, but not limited to:
- Primary responsibility is the routine activities associated with performing tests, test area, or quality systems, including preparing samples, running instruments, and/or administering quality programs. Including but not limited to:
- Collection of environmental monitoring samples in manufacturing areas to ensure an appropriately controlled environment meeting regulatory expectations and industry standards
- The ability to work nights and weekends providing environmental monitoring support is required as the Manufacturing schedule dictates.
- Routine environmental monitoring (viable and non-viable particulates)
- Water Analysis (Total Viable Count, absence of coliforms, Total Organic Carbon and Conductivity)
- Conduct Bacterial Endotoxin testing of water samples and product using Kinetic Turbidimetric Methods
- Perform Bioburden testing in support of sterilization validation and quarter dose audits
- Raw material and finish product release testing in accordance with compendia methods: Microbial Limit Test, and AET Test
- Author and review investigations and deviations in accordance with GMP guidelines
- Assist with method development, transfers, validations in accordance with GMP guidelines
- Assist with data system management
- Assist with ordering, receipt and stocking of laboratory supplies.
- Perform sample disposal and autoclaving of laboratory waste.
- Perform Quality Control testing of microbiology media and reagents.
- Author and review technical or quality methods, procedures, protocols, and reports in accordance with GDP
- Perform laboratory projects from set-up through data interpretation and reporting
- Possess strong technical, quality, and safety understanding to provide support to staff members and clients
- Performs both routine and non-routine assignments, utilizing a wide array of instrumentation
- Assists with training staff on methods, instruments, and quality principals
- Assist in equipment and facility maintenance investigations; investigates and facilitates the solving of any equipment/facility problems
- Strong time management abilities to ensure project deadlines are met
- A champion of cooperation and teamwork within the group and the company
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Minimum experience:
- B.S. in microbiology (or similar) with at least 1 year of relevant industry experience
- Experience using aseptic technique, autoclaves, and biosafety cabinets
- Experience testing air, personnel, and surfaces for active and non-active particulates
- Clean room and manufacturing environment experience
- Assist in the design and implement method development and validation studies.
- Ability to multi-task and interact with multiple groups in a team-oriented environment,
- The ability to read and understand relevant scientific literature, procedures, and protocols.
- Outstanding written and oral communication skills. Able to use correct business English, including spelling, grammar, and punctuation.
- Flexibility and outstanding time management skills to provide the full range of pharmaceutical support (including project representation) across multiple projects.
- Ability to read, analyze and interpret technical procedures and governmental regulations.
- Ability to effectively communicate information and respond to questions from groups of managers, and clients both verbally and in writing.
- Proficiency in computer applications and systems related to the work.
Work is performed in laboratory, cleanroom and office settings. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting. Cleanroom work is subject to being fully gowned for extended periods.
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.
This position is Monday through Friday first shift with the possibility of over time and weekend work if needed to meet the needs of our clients.