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location: Pearl River, New York
job type: Contract
salary: $24.00 - 26.56 per hour
work hours: 7 to 3
education: Bachelors
responsibilities:
- Downstream and Buffer Preparation: Responsible for all aspects of downstream processing and buffer preparation, including equipment preparation (CIP and SIP), raw material handling (FIFO), weighing and dispensing of materials, and material sampling for analytical testing.
- Equipment Operation and Maintenance: Operate and maintain ancillary equipment such as pH/conductivity meters, turbidity meters, tube welders, tube sealers, and peristaltic pumps.
- Manufacturing Quality: Interact with other departmental personnel to resolve manufacturing quality issues and ensure adherence to quality standards.
- Documentation and GDP Compliance: Ensure good documentation practices (GDP) are followed in the execution and review of production records.
- Training and Compliance: Complete all required cGMP training, including any additional training assigned by the manager, and work with Compliance to address deviations and CAPAs.
- Cleaning and Sanitization: Participate in the cleaning and sanitization of the cGMP facility and equipment in accordance with SOPs.
- Equipment Maintenance: Perform preventive maintenance and changeovers for area equipment, including biosafety cabinets and other in-process testing equipment.
- Problem-Solving: Identify issues, troubleshoot, propose solutions, and keep management informed of issues and progress.
- Cross-Training: Support cross-training initiatives and assist with database entry and other flex-area operations as needed.
- Assist in Manufacturing Processes: Participate in the execution of large-scale processes such as centrifugation, depth filtration, chromatography column purification, and tangential flow filtration.
- Work Environment Compliance: Follow established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
qualifications:
Required Skills:
- Education/Experience: High School diploma with at least 2 years of work experience or training in a cGMP manufacturing environment.
- cGMP Knowledge: General knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs).
- Documentation Skills: Strong attention to detail and good documentation skills for execution and review of production records.
- Manufacturing Skills: Ability to operate, maintain, and clean downstream processing equipment such as stainless steel vessels, peristaltic pumps, tube welders, tube sealers, etc.
- Analytical Skills: Ability to manage and analyze manufacturing data, identify issues, troubleshoot, and propose solutions.
- Communication Skills: Fluent in English, both written and spoken, with good communication and social skills.
- Aseptic Technique: Proficient in aseptic technique and preventive maintenance.
- Flexible Schedule: Ability to work a flexible schedule, including weekends and holidays, as required by the department.
- Baculovirus Expression Vector System (BEVS): Basic understanding of the BEVS manufacturing process is desired but not required.
- Equipment Knowledge: Familiarity with equipment like pH/conductivity meters, turbidity meters, magnetic mixers, and in-process testing equipment.
- Technical Troubleshooting: Ability to assist with troubleshooting in downstream and buffer preparation areas.
skills: SOP, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
