2nd shift Quality Control Operations Analyst -Sun-Wed

Within our Analytical Service team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company.

As a QC Operations Analyst, you will join the Cell and Gene Therapy Department to support QC operations in a fast-paced GMP environment. The ideal candidate will have GMP lab experience and excellent organization skills.
The candidate will need to be flexible to working at Boston/Cambridge depending on need.

Essential Functions:

• Work cross functionally with internal (facility, validation, metrology) and external (CTL, instrument vendors) teams to minimize day to day lab operations interruptions
• Identifying and creating processes that will ensure success within the QC lab
• Sample, reagent and chemical lifecycle management
• Establish, write, and update Standard Operating Procedures (SOPs) in compliance with GMP guidelines as needed in support of quality control operations
• Sets up and maintains instrumentation by working with the cross functional team (QC, QA, facility and vendors)
• Maintain QC equipment and perform regular performance verification/calibration as specified by equipment SOP
• Communicates project status to project leader.
• Performs work assignments accurately, and in a timely and safe manner.
• Shift work applies - 2 roles:

Candidate will train M-F then convert to one of the below shifts. Flexible during manufacturing runs - if working later, will have a later start time.

Sun – Wed

12:30 PM – 11:00 PM

3:30 PM – 2:00 AM (manufacturing run) at least 2x a month

Qualifications

Education and Experience:

• Bachelor's degree in Chemical Engineering, Scientific Field
  , or equivalent and relevant formal academic / vocational qualification
• Previous GMP lab experience that provides the knowledge, skills, and abilities to perform the job is preferred (0-2 years industry experience)
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• GMP experience preferred
• Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
• Proficient in Microsoft Excel and Word (LIMS is a plus)
• Proven problem solving and troubleshooting abilities
• Good written and oral communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team
• Able to lift and move objects up to 25 pounds.

$40-$43/hr