Quality Control Analyst

job summary:
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: $35 - 43 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Specific Biochemistry Focus Areas:
  • A280, SOLO A280, Compedia methods (pH. Moisture, OSMO,
    Appearance, Subvisible particles), Enzyme Actitity assays, DNA, PCR, Free Thiol
• 80%: Testing execution
• 10%: QC operations support which entails data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab housekeeping, support for other QC groups if needed.
• 10%: Compliance and quality systems (SOP revisions, input to quality system

 
qualifications:
Required:

• Bachelor's degree and minimum of 0-2 years related experience
• Prior use and/or application of basic GMP principles, theories and concepts.
• Knowledge of pharmaceutical industry practices and standards.
• Prior experience with MS Office, LIMS, SAP, Trackwise or EDMS

#LI-AM1

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 View email address on 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.