Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies. Testing may include but not limited to samples from drug substance/product and various protocol studies using test methods derived from the various compendia and non-compendial sources. The position is expected to maintain operational and GMP readiness of the QC area. In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects. Position is expected to act as a role model for junior staff in the various QC areas.
In addition, management, coaching, and mentoring of junior staff in the lab will be required.
location: Lexington, Massachusetts
job type: Contract
salary: $55 - 65 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Specific Cell Biology Focus Areas:
- Role is responsible for Cell Biology laboratories performing a broad range of techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing.
- Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.
- Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
- Specific QC Focus Area:
- Product testing: Areas of focus on techniques such as Western Blot, SDS-PAGE, ELISA Potency and Bioassays
- Receives assignments in the form of objectives and establishes goals to meet objectives. Provides guidance to subordinates to achieve goals in accordance with established policies. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which effect subordinate organizations.
- 40-50% Testing execution, participate in training analysts, trouble shooting of methods
- 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
- 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
qualifications:
Education & Qualifications
Required:
- Typically requires a bachelor's degree and a minimum of 4+ years of QC GMP experience.
- 1-2 years or prior qPCR experience
- Experience with ELISA and other bioassays
- 5S/OE experience
- Experience with Method transfers
- Experience with MS Office, LIMS, SAP and Trackwise, and an understanding how to use them as it relates to compliance and the related science
- Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
skills: Quality control, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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.
