Back to search
Description:
The Operator III, Manufacturing - Cancer Test Kits
Responsibilities
- Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions.
- Assist with batch record reconciliation and timely documentation.
- Performance of all manufacturing activities in clean room (ISO 7) environment with specialized sterile gowning.
- Execution of cell manufacturing and cell processing activities in closed systems and maintaining aseptic technique during processing to ensure highest integrity, viability and sterility of cellular product until release.
- Work as a part of the team to execute all necessary GMP runs for cell manufacturing in an accurate and timely manner
- Perform accurate and error-free calculations of cell concentrations, cell and media dilutions and cell viability throughout the entire cell manufacturing process workflow.
- Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
- Acts as On-The-Job-Trainer for a variety of job functions
- Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
- Critical evaluation of processes, including foresight and thinking ahead.
- Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
- Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.
- Perform timely consumption of materials and completion of quality documentation in appropriate systems
- Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. · Work to complete documentation of deviations and events in appropriate systems
- Execute validation protocols with minimal supervision or direction
- Participate in cross-functional teams to complete projects
Additional Skills & Qualifications:
Minimum Qualifications:
- BS or MS in biological science or engineering discipline
- Equivalent combinations of education, training, and relevant work experience may be considered.
- 2-5 years of relevant cGMP experience in a manufacturing pharmaceutical/biotech environment or related areas
- Experience in aseptic cell culture processing in IOS 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred
- Strict adherence to SOPs, GMP regulations, FDA guidance and ability to accurately complete associated documentation required
Knowledge, Skills, Abilities
Strong written and oral communication skills
Understanding ‘why’ and not just the ‘how’ of processes and practices
Knowledge of cGMP practices required
Knowledge of deviation investigations preferred
Knowledge of cell culture and aseptic techniques strongly preferred
MS Office
Strong math skills
Strong prioritization skills
Detail oriented
Results driven
Strong communication skills with ability to read, write, and communicate in English
Effectively multi-task
Able to work independently and as part of a team
Able to recognize problems developing, not just occurring
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
