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A background in cell culture, aseptic gowning and qualification, and/or ISO class 7 cleanroom operations is preferred, but not required.
Responsibilities
- Complete training sessions and ensure training documentation is maintained.
- Proficiently carry out procedures to achieve a consistent, error-free execution of daily job assignments
- Work as part of a team to produce each lot; accurately and fully complete batch records, forms, and documentation.
- At all times, understand and comply with quality standards and safety guidelines
- Perform materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
- Identify errors and report them promptly to lab management. Participate in root cause analysis and implement corrective actions.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Other duties as assigned.
Qualifications
- Minimum A.S. degree in biology, chemistry, or related technical field, or equivalent industry experience.
- Minimum of 0-2 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is preferred, but not required.
- Able to accurately perform basic math, including fractions, decimals, and percentages.
- Able to work effectively with team members and show initiative to assist others on the team when needed
- Able to work successfully in a fast-paced team-oriented environment.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Must adhere to the clients core values, policies, procedures, and business ethics.
- Aseptic Processing Technicians are required to work their assigned schedule. This position is currently for regular work week hours (1st shift M-F); however, due to the nature of processing schedules, must be willing to move to a 2nd shift, weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change and may involve shift changes (i.e. Tuesday to Saturday). May be required to work overtime.
- Able to read, write and understand English, and be proficient in Microsoft Office (Excel, Word, Outlook).
Physical Requirements:
- Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
- Able to don cleanroom garments and personal protective equipment (scrubs, gowning coverall, masks, gloves, goggles).
- Able to see at near and mid-range with depth perception.
- Able to stand/sit/walk for long periods of time.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Able to lift 20 lbs.