Associate Quality Control Lab

Payrate: $32.00 - $35.00/hr.
 
Summary:
This person will be responsible for working in the Quality analytical laboratory, using GMPs and GDPs to execute analytical testing.
 
Responsibilities:

• Performing analytical testing including time sensitive samples from Manufacturing (Titer/ MMV/ Mycoplasma/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Protein Concentration via UV/VIS and HPLC, 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

 
Qualifications:

• 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

 
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
• 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

 
Top 3 Must Have Skill Sets:

• Ability to work in a fast paced, GMP environment
• Familiarity with Quality ideology (GDP, GMP, etc.)
• Technical skill in wet chemistry, HPLC, microbiology, USP/EP testing

 
Pay Transparency: The typical base pay for this role across the U.S. is: $32.00 - $35.00 /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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