Associate I, QC Analytics (Contract)

ElevateBio; Waltham (MA); On-site; USD 45,000 - 59,000; Full time

Job summary

ElevateBio is seeking a QC Associate to support GMP testing in QC laboratories at the BaseCamp facility in Waltham. You will perform cell and molecular biology assays and assist in maintaining lab operations for gene and cell therapy programs.

Responsibilities include routine testing, data recording, peer-review, investigations of excursions, deviations, CAPAs and OOSs, and cross-functional collaboration to qualify assays. Prior GMP experience and familiarity with LIMS/QMS/ERP are a plus.

Qualifications

• Bachelor’s or Master’s degree in a technical discipline (Biology/Molecular Biology/Biochemistry/Chemistry or related field).
• 1–5 years of experience with a Bachelor’s, 1–3 years with a Master’s.
• Experience in GMP setting preferred.
• Experience with cell and gene therapy test methodologies (PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).
• Excellent organizational skills and attention to detail.
• Ability to work independently and collaborate with technical personnel.
• Experience performing laboratory investigations.
• Knowledge of GMP, SOPs, and Quality System processes.
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.

Responsibilities

• Perform routine testing using established test methods and report data.
• Peer-review data records and testing reports.
• Assist with investigating testing excursions, deviations, CAPAs and OOSs.
• Collaborate with QC to meet timelines.
• Share responsibility for inventory and daily lab operations.
• Assist qualification of developed assays with Analytical Development.
• Draft or edit procedures for testing and/or equipment.

Skills

Cell & molecular biology

GMP experience

Test methods: PCR

Flow Cytometry

ELISA

Cell culture

Cell-based assays

Organizational skills

Independent worker

LIMS/CMMS/QMS/ERP exposure

Education

Bachelor’s or Master’s in Biology/Biochemistry/Chemistry

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role:

The QC Associate will support GMP testing in QC laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for performing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate may assist in qualifying these assays.

Here’s What You’ll Do:

• Perform routine testing using established test methods, analyze the results, and record/report the data.
• Perform peer-review of data records and testing reports.
• Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.
• Collaborate with other QC functions to ensure all testing is completed within established timelines.
• Share responsibility with peers to manage inventory and reagents, and perform maintenance and other daily lab operations.
• Work cross-functionally with Analytical Development and other QC functions to assist in the qualification of developed assays.
• Assist in drafting and/or editing procedures for testing and/or equipment.

Requirements:

Bachelor’s, or Master’s, degree in a technical discipline (Biology/Molecular Biology/Biochemistry/Chemistry or related field). 1-5 years of experience with a Bachelor’s, 1-3 years with a Master’s.

Experience working in a GMP setting preferred.

Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).

Excellent organizational skills and attention to detail.

Ability to work independently as well as communicate and collaborate with scientific/technical personnel.

Experience performing laboratory investigations.

Knowledge of GMP, SOPs, and Quality System processes.

Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.

* Multiple positions available at Associate I level.

* Contract length is 9 months.

The budgeted range for this position is $33/hour - $43/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.