QC Specialist (SRG) - new job in Lexington, US

QC Specialist II

Duration - 1 year

Location - hybrid /remote Lexington, MA

Currently the client is looking for a QC Specialist II to help with support of the QC functions.

This person will be responsible for developing solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships internally and externally.

Job Requirements:

• Experience in data analysis and statistical analysis using Minitab or JMP
• This position will require experience with method validation lifecycle activities Must be well versed in using platforms such as Microsoft Word, Powerpoint, Excel, Teams, as well as be familiar with document authoring and editing activities.Frequent cross-functional interaction with upstream manufacturing development, manufacturing, equipment validation, and QC teams. Some experience with cell counting methods and protein concentration methods is preferred as well as project management skills. The candidate will interact with multiple and often concurrent
• project teams of varying levels of experience in method validation; therefore, communication and consistency are key to success.
• Candidate is expected to be involved in any of the following: analytical method transfer, analytical method validation, data analysis,data trending, project and testing coordination product and material specification management, inspection support, document authoring, revisions, initiating/completing quality systems, method/equipment validation and method projects activities. Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask.Conducts work in compliance with cGMPs, safety and regulatory requirements. project teams of varying levels of experience in method validation; therefore, communication and consistency are key to success. Candidate is expected to be involved in any of the following: analytical method transfer, analytical method validation, data analysis, data trending, project and testing coordination product and material specification management, inspection support, document authoring, revisions, initiating/completing quality systems, method/equipment validation and method projects activities.

Technical Services:

Area is focused on data analysis, data trending, project and testing coordination product specification management, LIMS interface, CoA generation, (including interaction with the IT systems such as LIMS that enables electronic management of this activity), and inspection support.

Essential:

Experience in Analytical Method Transfer, Analytical Method Validation, HPLC, Bioassays, CE assays, compendial verification, biologics

Additional Specific Experience:

• Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment.
• Ability to prioritize work and multitask.
• Conducts work in compliance with cGMPs, safety and regulatory requirements.-Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases

-Ability to walk and stand for periods of time

-Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

Education/Skills:

Normally requires a bachelor’s degree and a minimum of 2 years of related experience. (Science related degree is preferred)

Key Skills:

MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding