Quality Control Laboratory Analyst Jobs in Massachusetts

Three or more years of industry lab experience with HPLC, GC, GC/MS, LC/MS, ICP-MS, NMR required

GMP and ISO experience a plus

Hands-on experience with Biovia LIMS/LES system strongly preferred, Cheminformatics experience a plus

Must be able to multi-task in a fast-paced environment and possess strong verbal and written communication skills

Responsible for troubleshooting basic issues with supervisory oversight

Responsible for basic maintenance of equipment

One or more years of industry lab experience with benchtop chemistry experience required; QC experience preferred; GMP experience a plus

Hands-on experience with Biovia LIMS/LES system preferred; Cheminformatics experience a plus

Must be able to multi-task in a fast-paced environment and possess strong verbal and written communication skills

Follow documented procedures and document test data as required

Write test procedures as required

Any additional functions as assigned

Provide support to QC management, including routine testing, project management and lab operations

Extensive knowledge and hands-on experience performing analytical assays such as SDS-PAGE IEF, SEC and HPLC.

Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements

Assist in equipment qualification / validation activities, including maintenance

3-5 years Quality Control experience in a cGMP organization

Strong experience with Bioassays (CHO), ELISAs, qPCR, and other molecular biology techniques

Working experience in a cGMP environment is preferred.

Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.

Must have effective written and verbal communication skills.

Monitor, compile, and review analytical and QC data individually and with team members.

Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.

Create and maintain clear, concise records and documentation.

Assists in the implementation of the Laboratory Information Management System.

Contribute to establish a reference standard program and sample management system.

Conduct raw material qualification per approved SOPs.

Minimum of bachelor’s degree in biochemistry or related scientific field with at least two years of relevant experience.

Experience with bioassays, preferable in a QC environment.

Hands-on experience with molecular and cell biology techniques such as flow cytometry, PCR, and ELISA/Multiplex.