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 and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.
location: Lexington, Massachusetts
job type: Contract
salary: $40.00 - 52.84 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Specific Biochemistry Focus Areas:
- Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., 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.
- 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:
Required:
- Typically requires a Bachelor's degree and a minimum of 5+ years of related experience. (science related degree is preferred)
- 1-2 years of prior experience with qPCR.
- Prior experience with MS Office, LIMS, SAP and TrackWise
- Strong understanding of relevant compliance and science.
- Previous experience in a GMP QC role is preferred
skills: Quality control, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System, Polymerase Chain Reaction (PCR)
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.
