Assistant QC Scientist

ASSISTANT QC SCIENTIST DEVENS, MA Required Skills:

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, a related discipline, or its equivalent.
• Minimum 4 years of experience .
• Problem solving ability, interpersonal, oral, and written communication skills as well as technical writing skills.
• Able to prioritize objectives from multiple projects, adhering to scheduled timelines.
• Work independently and contribute to a team-based environment, promoting a high commitment to business goals and objectives.
• Computer skills required: Microsoft Office applications.
• LIMS and data management system experience is desired.
• Excellent organizational skills and attention to detail.
• A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in biologics manufacturing facility is desired .
• Lead investigator and/or Quality Assurance experience is preferred, but not required.
• Direct daily interaction with all staff and management of Global Biologics Stability.
• Regular interaction with network departments within and outside of the facility as required in the conduct of assigned work and to align with sample shipping and receipt processes.

DECISION MAKING :

• Exercises judgment within generally defined practices and policies in developing improved business processes.
• Coordinates with customers and technical experts on decisions and applies appropriate notification to management.

WORKING CONDITIONS :

• The work environment may consist of a combination of the following:
  • Office space, Inside Work, Outside Work, Working Alone, Working with/around others, Extremes (Heat/Cold), Heights, Dust/Mist/Fumes/Wet, Damp/Walking or Work Surfaces, Chemicals.
  • The physical demands of the job may include but are not limited to: Unassisted lifting of items, not to exceed 50 lbs, Bending/Stooping, Twisting, Crouching/Squatting, Kneeling, Sitting, Crawling, Walking-Level Surfaces, climbing (Ladder), Reaching (Shoulder), Repetitive (Use of Arm, Hands, Wrists), use of box cutter, ability to adhere labels to small vials and syringes.

Project Description:

• Provide Stability Administration Support for the department, including but not limited to enrollment activities (form creation, archival, tracking, etc.), product data entry and tracking, document management activities.
• Draft study protocols and support management of study programs as required.
• Author and/or revise GMP documents.
• Data entry and verification in the electronic Laboratory Information Management System (LIMS) .
• Create stability data tables.
• Perform data verification and report unusual trends to management for review.
• Escalate information regarding impact to stability program promptly.
• Support activities of Stability Third Party sample storage facility including but not limited to inventory control, sample receipt support, labeling, sample destructions, sample pulls and oversight of sample deliveries, etc.
• Ensure training requirements are met.
• Maintain cGMP practices and comply with HA expectations .

This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Jim: ALPHA'S REQUIREMENT #22-03297 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE