2nd shift Quality Control Operations Analyst -Sun-Wed (Contract) 999

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 55,000 - 59,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston/Cambridge is seeking a QC Operations Analyst to support QC operations in a fast-paced GMP environment. The role requires GMP lab experience and strong organizational skills, with flexibility to work on site in Boston/Cambridge.

Responsibilities include SOP development, instrument setup, sample lifecycle management, and cross-functional collaboration to minimize interruptions in lab operations.

Qualifications

• Bachelor's degree in Chemical Engineering, Scientific Field, or equivalent.
• GMP lab experience preferred (0–2 years).
• Equivalency may be considered with related education/training/experience.

Responsibilities

• Collaborate cross-functionally with internal and external teams to minimize lab interruptions.
• Develop processes to ensure QC lab success.
• Manage sample, reagent and chemical lifecycles.
• Write/maintain SOPs in GMP compliance as needed.
• Set up and maintain instrumentation with cross-functional teams.
• Maintain QC equipment and perform calibration/verification as per SOPs.
• Communicate project status to the project leader.
• Perform tasks accurately, timely and safely.
• Shift work: Sun–Wed, with flexible timing during manufacturing runs.

Skills

GMP lab experience

Microsoft Excel

Microsoft Word

Problem solving

Time management

Team collaboration

Documentation

Education

Bachelor's degree in Chemical Engineering or scientific field

Tools

LIMS

Job description

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