Quality Control Associate

Aditi Consulting; West Greenwich (RI); On-site; USD 41,000 - 45,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Health savings accounts

Paid time off

Bereavement leave

401(k) with employer match

Discretionary bonus

Job summary

Aditi Consulting is seeking a Laboratory Quality Assurance Analyst to perform analytical testing on time-sensitive samples, ensuring GMP compliance and accurate documentation. You will operate equipment, review assays, and support troubleshooting across manufacturing and raw material testing, with an emphasis on data integrity and regulatory adherence.

The role requires strong communication, ability to work independently, and familiarity with QC systems.

Qualifications

• Experience in analytical laboratory testing with ability to plan and perform routine tasks efficiently.
• Excellent written and verbal communication skills.
• Strong focus on data integrity in laboratory settings.

Responsibilities

• Perform analytical testing including time-sensitive samples across manufacturing and materials.
• Ensure compliance with safety guidelines and cGMP regulations.
• Generate accurate, complete lab documentation using electronic systems.
• Operate laboratory equipment and instrumentation.
• Review and approve assays, documents and records.
• Support troubleshooting and problem solving.
• Alert management to quality, compliance, and safety risks.
• Assist with TRAs and deviations as applicable.
• Complete required training for assigned tasks.
• Perform additional duties as assigned by management.
• Support sample sweeps and aliquoting; perform Endo, Bioburden, Titer, and compendia testing.

Skills

Analytical testing

Data integrity

Documentation

Communication

GMP/cGMP

Independent work

Biopharma knowledge

Education

Bachelor’s degree or higher

Associate’s degree + 1-2 years

Tools

Laboratory equipment

QC analytical systems

Job description

• 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
• Support Sample Sweeps and Aliquoting. Perform Endo, Bioburden, Titer and Compendia testing.

Payrate: $30.00 - $33.00/hr

Responsibilities:

• 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
• Support Sample Sweeps and Aliquoting. Perform Endo, Bioburden, Titer and Compendia testing.

Qualifications:

• 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

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
• Bachelor’s degree OR Associate's degree and 1-2 years of Quality or Analytical Laboratory experience OR High school diploma/GED and 3 years of Quality or Analytical Laboratory experience

Top 3 Must Have Skill Sets:

• Experience executing analytical testing per Method and or Compendia
• Experience with Quality Control system/GMP/cGMP/ Sample management or Microbiology background.
• Excellent interpersonal, written and verbal communication skills

Pay Transparency:

The typical base pay for this role across the U.S. is: $30.00 - $33.00/hr.Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law.

Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience.

Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

• medical, dental, and vision benefits
• health savings accounts with qualified medical plan enrollment
• 10 paid days off
• 3 days paid bereavement leave
• 401(k) plan participation with employer match
• life and disability insurance
• commuter benefits
• dependent care flexible spending account
• accident insurance
• critical illness insurance
• hospital indemnity insurance
• accommodations and reimbursement for work travel
• discretionary performance or recognition bonus
• Sick leave and mobile phone reimbursement provided based on state or local law