QC Scientist II

Job title: QC Scientist II

Location: Lexington, MA

Duration: 06 Months on W2 + High possibilities of extension

Shift: Mon - Fri 8 AM – 5 PM

Job Description:

Position Summary:

· This position will work in the GMP QC Laboratories to qualify and conduct chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured.

· Supports analytical test method validation and transfer activities at and between external sites for PCR.

· Will perform routine assays and testing including but not limited to ddPCR, pH, appearance, osmolality, SDS page, and ELISAs.

· Responsible for coordinating or chipping into sophisticated projects of moderate Product within QC and cross-functionally.

· Independently manages analytical reference standard programs for commercial drug substances and drug products including qualification /requalification, inventory, supply / shipping.

Responsibilities:

· Independently apply scientific judgment and contribute to landmarks related to specific projects.

· Represent QC business processes and needs within the department and at cross functional forums.

· Apply proficiency in analytical techniques within and outside of your specific group.

· Resolve technical and tactical operations problems, communicate to collaborators in a timely manner.

· Ensure sample testing achievements are met and supervise due dates through completion to meet or exceed metrics

· Ensure method performance and sample data trending is kept up to date

· Maintain cGMP and GDP compliance within their laboratories

· Generate, revise, and/or approve SOP or test methods

· Review and ensure training requirements are completed and maintained for analysts and self

· Maintain a safe working environment in the laboratory and participate in safety and compliance inspections

· Support regulatory inspections and audits

Education
Bachelor's degree in Chemistry, Biology or other related scientific field - required.
Experience
2+ years' experience with relevant laboratory experience in a regulated manufacturing or QC laboratory environment; 3-7 years preferred.

Knowledge, Skills, Abilities

· Applied knowledge and in-depth understanding of GMP Quality Control systems.

· The candidate must have analytical experience with molecular techniques compendial methods.

· Proven problem solving ability, interpersonal, oral and written communication skills

· Ability to prioritize objectives from multiple projects and scheduled timelines while maintaining flexibility and attention to detail

· Understanding of applicable regulatory requirements.

· Must be proactive, committed and have the ability to adapt to a change.

· Experience with electronic systems such as LIMS and Trackwise is an advantage.

· Significant laboratory documentation review and revision experience.

#IRI3

Job Type: Contract

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person