The Central Services Technician I will be expected to support the execution of GMP manufacturing batch records and ensures necessary supply levels in the manufacturing areas. This role is also responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk products from microbial and cell culture systems for GMP manufacturing. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and employee
Key Responsibilities include but are not limited to:
Execution of manufacturing batch records, SMP's, work instructions, and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive right the first time executions.
Documentation of all activities to meet cGMP requirements.
Proven ability to utilize central services processing equipment according to established SOPs. This equipment includes but is not limited to biological safety cabinets, various mixers, autoclaves, washers, balances/scales, Ph/ Conductivity meters.
Help identify and support the implementation of Continuous Improvement opportunities.
Have the ability to identify Waste within work processes.
Identify Cost Savings projects / Initiatives
Adhere to all cGMPs, compliance/regulatory mandates, and quality requirements.
Review his/her daily GMP documentation for accuracy and completeness(Logbooks, SMP, & Batch records)
Education & Experience:
High school diploma or GED required
1-2 years' experience working in a GMP facility preferred (will consider reduced experience with increased levels of education in applicable discipline)
Strong communication skills
Must be able to lift up to 25lbs minimum
Basic computer skills including Microsoft Office
Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic.
Must be flexible, adaptable, self-motivated, and able to work well independently and across teams and partners.
Perform other related duties as assigned to meet departmental and Company objectives.
Ability to develop and maintain strong working relationships with primary support functions.