Quality Control Operations Analyst -Wed-Sat (Contract) 23119
Job Description:
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.
Wed-Sat
7:00 AM – 5:30 PM
5:00 AM – 3:30 PM (manufacturing run) at least 2x a month
Wed-Sat
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.
Pay Range:
$30-$35/hr + shift differntial
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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No C2C or Third-Party Vendors