Job Description

Fully Onsite - 8-5 (Flexible)

The ideal candidate will have 1–2 years of hands-on experience in a GMP-regulated lab, with strong proficiency in HPLC, capillary electrophoresis, and general chemistry testing (e.g., pH, osmolality, sub-visible particles). They must be able to troubleshoot lab instrumentation, demonstrate a strong sense of data integrity, and clearly articulate their role within a team. Candidates without GMP experience or with solely academic/microbiology backgrounds will not be considered. The team requires someone who can quickly contribute with minimal training. Please no Microbiology candidates they are not fit for the role.

Job Details: Under general supervision, this position will perform routine procedures to support drug substance and drug product testing within Quality Control. Tasks may include but are not limited to performing sample collection, sample handling, testing equipment/laboratory support. This position will be responsible for one or more of the following activities: - Performing routine laboratory procedures - Documenting, computing, compiling, interpreting, and entering data into computerized systems- 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 notebooks.

What we are looking for:

• Experience in GMP analytical laboratory

• Experience with HPLC/UPLC, general chemistry, capillary electrophoresis

• Experience with analytical laboratory testing with the ability to plan and perform routine tasks with efficiency and accuracy.

• Must have focus on data integrity

• Qualified to work in the U.S. without employer sponsorship

• Commitment of a 40-hour work week in West Greenwich, RI

Experience:

o Master's degree

OR

o Bachelor’s degree and 1-2 years of Quality or Analytical Laboratory experience

OR

o Associate's degree and 3-5 years of Quality or Analytical Laboratory experience

OR

o High school diploma/GED and ?5 years of Quality or Analytical Laboratory experience

Preferred Qualifications

• Ability to work independently and deliver right first time results

• Excellent communication skills (written and verbal)

• Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision

• Strong communication skills (both written and oral), facilitation and presentation skills

• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.

• Understanding of biopharmaceuticals process and related unit operations

• Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy

• Independent, self-motivated, organized, able to multi-task in time-sensitive environments.

• Demonstrated experience in investigations and QC processes

Basic Qualifications

High school/GED + 2 years work experience OR​ Associates and 6 months work experience OR​ Bachelors

Top 3 Must Have Skill Sets:

• Experience with HPLC/UPLC, general chemistry, capillary electrophoresis

• Experience with GMP analytical laboratory testing with the ability to plan and perform routine tasks with efficiency and accuracy.

• Must have focus on data integrity

Day to Day Responsibilities:

Routine analytical testing of drug substance/product and stability samples using HPLC, CE, and General Chemistry methods. Working with the team to complete daily tasks on time in full and daily check ins with management to track progress.

Job Tags

Similar Jobs