The candidate in this role will support cGMP QC routine testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, leading method transfers, qualification activities, quality records (e.g. Change Controls, CAPAs, ECs, Investigations), and ensuring compliance with cGMP standards. The individual will teach and train analysts on technical concepts and methods and act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development.
location: Norwood, Massachusetts
job type: Contract
salary: $30.00 - 37.17 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities.
- Support bioassay routine testing for raw materials, drug substance and drug product.
- Lead special projects as Bioassay SME.
- Perform on the job training.
- Write/revise SOPs, protocols, and reports.
- Troubleshoot issues related to equipment, laboratory procedures and assay performance
- Establish and maintain a safe laboratory working environment.
- Analyze and trend data assigned
- Review Data
- Own and manage Quality records (i.e. investigations, change controls, CAPAs)
- Ensure compliance with cGMP documentation and regulatory guidelines
- Accountable for all mandatory training and assigned tasks.
- Provide support during audits and collaborate on continuous improvement initiatives.
- Establish and maintain a safe laboratory working environment.
- Additional duties may be assigned.
qualifications:
- BS Degree
- Experience: STEM degree with minimum 5 years of experience in a cGMP laboratory, with hands-on experience in Mammalian cells, Cell-based Assays, ELISA, Protein Analysis, In Vitro Relative Protein (IVRPE).
- RFT (Right First Time) in execution.
- Method validation/qualification cell-based assays, or protein analysis methods.
- Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)
- Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet
- Experience with laboratory equipment calibration and maintenance.
- Ability to work effectively in a fast-paced, cross-functional matrix environment.
- Working knowledge and application of FDA, EU, ICH guidelines, and regulations.
- Experience providing technical training.
- Experience in technical writing.
skills: Microbiology, Laboratory Information Management Systems (LIMS), Cell Cultures, Capillary Electrophoresis (CE), Polymerase Chain Reaction (PCR), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Deviation Investigation, Food and Drug Administration (FDA), International Council for Harmonization (ICH), Quality Management Systems (QMS)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
