Quality Control Associate (HPLC, Microbiology, GMP)

Description:

Weekday shift: - Tuesday – Friday (9:45pm – 8:15am)

Weekend Shift - Saturday – Tuesday (9:45pm – 8:15am)

Ideal Candidate: Science related degree, HPLC, Microbiology, GMP knowledge,

Nice to have: Wet Chemistry

Quality Control is searching for an analyst (Associate QC) to support routine testing for the QC Night Shift “Team D” (Tuesday-Friday from 9:45pm – 8:15am).

This person will be responsible for working in the Quality analytical laboratory, using GMPs and GDPs to execute analytical testing.

The ideal candidate enjoys tackling challenges and excels at time management with attention to detail.

Responsibilities will include, but are not limited to:

• Performing analytical testing including time sensitive samples from Manufacturing (Titer/ MMV/ Mycoplasma/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot.

• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices and other applicable regulations

• Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks

• Operates laboratory equipment and instrumentation

• Performs review and approval of assays, documents and records

• Supports troubleshooting and problem solving

• Alerts management of quality, compliance, supply and safety risks

• Supports TRAs and deviations, as applicable

• Completes required assigned training to permit execution of required tasks

• Performs additional duties as specified by management

What we are looking for:

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

• Demonstrated ability to work independently and deliver right first time results

• Excellent communication skills (written and verbal)

• Must have focus on data integrity

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

• Commitment of a 40-hour work week (4 x 10hr shifts) in West Greenwich, RI

Experience:

o Bachelor’s degree

OR

o Associate's degree and 1-2 years of Quality or Analytical Laboratory experience

OR

o High school diploma/GED and 3 years of Quality or Analytical Laboratory experience

Preferred Qualifications

• 1-3 years of experience in GMP analytical laboratory

• Experience executing analytical /biological testing per Methods and/or Compendia

• Experience with QC analytical systems and/or Quality systems

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

• Strong communication skills (both written and verbal)

• 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 degree and 6 months work experience or Bachelors degree

Top 3 Must Have Skill Sets:

• Strong Analytical Skills – Ideal candidate will have at least 1-3 years of experience performing analytical testing

• Attention to Detail – Ideal candidate will be thorough and deliver polished work product.

• Can Do Attitude – Ideal Candidate will have a positive attitude and be willing to participate in lean initiatives on site.

Day to Day Responsibilities:

• Daily responsibilities will be focused on executing analytical testing across multiple laboratories in a GMP laboratory.