2nd shift Quality Control Operations Analyst -Sun-Wed (Contract) 916

Vertex Pharmaceuticals LLC; Boston (MA); Presencial; USD 55.000 - 59.000; Jornada completa

Descripción de la vacante

Vertex Pharmaceuticals is seeking a QC Operations Analyst to support QC operations in a fast-paced GMP environment within the Cell and Gene Therapy Department. The role requires GMP lab experience and strong organizational skills, with potential shifts rotating including Sun-Wed schedules in Boston/Cambridge.

The position involves cross-functional collaboration with facility, validation, metrology, and vendors, plus SOP creation, instrument setup, calibration, and timely project communications.

Formación

• Bachelor's degree in Chemical Engineering, Scientific Field, or equivalent and relevant formal academic / vocational qualification.
• GMP lab experience preferred (0-2 years industry experience).
• An equivalency consisting of education, training and/or related experience may be considered.

Responsabilidades

• 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 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 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: Sun – Wed 12:30 PM – 11:00 PM; 3:30 PM – 2:00 AM (manufacturing run) at least 2x a month

Conocimientos

GMP lab experience

Microsoft Excel

Microsoft Word

Communication skills

Time management

Project management

Team collaboration

Physical lifting 25 pounds

Educación

Bachelor's degree in Chemical Engineering or related field

Herramientas

LIMS

Descripción del empleo

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.

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.

Pay Range

$40-$43/hr

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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