Quality Control Associate

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. 

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