Quality Control Senior Associate

Merck & Co.; West Greenwich (RI); On-site; USD 65,000 - 90,000; Full time

Job summary

Merck & Co. in Rhode Island is seeking an on-site laboratory professional to support bioanalytics testing including HPLC/UPLC and capillary electrophoresis under mentorship from the front-line manager.

The role requires following cGMP practices, generating precise lab documentation, and contributing to investigations and continual improvement initiatives in a regulated environment.

Qualifications

• Experience with HPLC/UPLC, capillary electrophoresis, and related chemistry testing methods.
• Experience in laboratory investigations, method validation, audits, QC processes.
• Ability to interpret scientific data.
• Self-motivated with strong organizational skills and ability to manage multiple tasks with minimal direction.

Responsibilities

• Follow safety guidelines, cGMPs and other applicable regulatory requirements.
• Generate complete, accurate, and concise laboratory documentation using electronic systems and notebooks.
• Ensure facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other regulations.
• Operate laboratory equipment and instrumentation.
• Perform review and approval of assays, documents and records.
• Support Continual Improvement initiatives.
• Alert management of quality, compliance, supply and safety risks.
• Participate in laboratory investigations.
• Perform general laboratory housekeeping activities.
• Complete required trainings to carry out tasks.
• Perform additional duties as specified by management.

Skills

HPLC/UPLC

Capillary electrophoresis

Data interpretation

Organization & multitasking

cGMP compliance

Tools

HPLC/UPLC instruments

Capillary electrophoresis equipment

Job description

100% Onsite - Rhode Island

Urgent backfill of AMAGJP00015468 (scrubbed resume attached)

Urgent role shortlisting EOD Tuesday 7/28

Standard 8-5 local hours

The role will be on-site based out of *** Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing the following: in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including: HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.

Responsibilities

• Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
• Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
• Operate laboratory equipment and instrumentation
• Performs review and approval of assays, documents and records
• Supports Continual Improvement initiatives
• Alerts management of quality, compliance, supply and safety risks
• Participate in laboratory investigations
• Perform general laboratory housekeeping activities
• Completes required assigned training to permit carry through of required tasks
• Performs additional duties as specified by management

Preferred Qualifications

• 1-2 years' experience in HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing
• Demonstrated experience in laboratory investigations, method validation, audits, QC processes
• Proven ability to interpret scientific data
• Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction