Candidates must have an educational background in Chemistry or Biology, along with experience in GMP within the biotech or pharmaceutical industry, with a focus on pipetting techniques.
A minimum of 2 years of GMP experience is preferred. Proficiency in software tools such as Teams, Excel, and Word is essential.
Familiarity with SharePoint, SmartSheets, or LIMS is a plus. Strong communication skills are also a key requirement for this role.
Job Details:
Under general supervision, this position will perform routine procedures and testing in support of the lab.
This position will be responsible for one or more of the following activities: - Performing routine laboratory procedures - Routine analytical testing - Documenting, computing, compiling, interpreting, and entering data - Maintaining and operating specialized equipment - Initiating and / or implementing changes in controlled documents.
Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.
Responsibilities include:
Responsible for one or more of the following activities in QC: analytical testing, sample and data management and equipment maintenance.
Perform routine laboratory procedures such as sample analysis, standard and solution preparation.
Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data.
Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.
Support introduction of new methods/techniques into the lab.
Perform basic assay and instrument troubleshooting.
May identify, recommend and implement improvements related to routine job functions.
Must learn and comply with safety guideline and basic cGMPs
Must be flexible in working schedule as required
Must be able to be on-call for CEMS as required
Preferred Qualifications
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to organize work, handle multiple priorities and meet deadlines
Strong written and oral communication skills
Must be detail orientated
Must be flexible and adaptable to changing priorities and requirements?
Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance?
Demonstrates understanding of when and how to appropriately escalate.?
May identify, recommend and implement improvements related to routine job functions.?
Must learn and comply with safety guideline and cGMPs.
Top 3 Must Have Skill Sets:
Pipetting
Influential leadership and project management skills to drive teams to meet project milestones
Very organized in thinking, ability to coordinate multiple tasks and deadlines and through collaborations assign deadlines and accountability with internal and external partners
Detail oriented, self-motivated, and ability to pro-actively manage tasks and identify improvement opportunities
Pay Rate between $23 - $27/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"