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Seeking an Aseptic Operator to join a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology!
Description:
• Assist with initial/subsequent validation of a new area, including manufacturing equipment and processes.
• Collaborate with cross-functional teams, including Quality Assurance, Quality Control, and Maintenance to troubleshoot issues and resolve deviations.
• Participate in aseptic process simulations, media fills, and equipment qualifications.
• Participate in in-process inspections and quality control checks to verify the integrity of product quality.
• Complete applicable logbook, form, and batch record documentation as required while adhering to strict cGMP and Good Documentation Practices.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance processes, reduce waste, and increase efficiency.
• Complete initial aseptic gowning and process qualification and maintain qualification to work within Grade A and Grade B cleaning environment.
• Comply with policies, guidelines, and regulatory requirements of the Quality System and applicable current Good Manufacturing Practices (cGMPs).
• Other duties as required and assigned by management.
Additional Skills & Qualifications:
• High school diploma or equivalent; additional technical or vocational education is a plus.
• Minimum 1 year experience working in the pharmaceutical/biopharma/biotech industry and within aseptic clean room environments.
• Knowledge of aseptic gowning/ techniques, cleanroom protocols, and cGMP
• Ability to read and comprehend work instructions and standard operating procedures
• Ability to understand equipment alarms and escalate as necessary.
• Exceptional attention to detail, accuracy, and documentation skills.
• Ability to work in a controlled aseptic environment, following gowning and hygiene protocols.
• Good communication skills and the ability to work collaboratively in a team-oriented environment.
• Flexibility to work in shifts, including evenings, nights, weekends, and holidays, as required by production schedules.
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.
