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Quality Control Senior Associate

Aditi Consulting

Holly Springs, NC

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JOB DETAILS
SALARY
$37–$39 Per Hour
SKILLS
Analysis Skills, Analytical Chemistry, Artificial Intelligence (AI), Assays, Automotive Automation, Biological Assay, Biotech and Pharmaceutical, Chemistry, Consulting, Documentation, GMP (Good Manufacturing Practices), Health Plan Membership, Hospital, ISO (International Organization for Standardization), Insurance, Laboratory, Laboratory Information Management System (LIMS), Maintain Compliance, Manufacturing, Messaging Technology, Microbiology, Organizational Skills, Polymerase Chain Reaction (PCR), Process Improvement, Project Management Software, Purchasing/Procurement, Quality Control, Quality Management, Receiving Inspection, Regulations, Reimbursement, SAP, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), Telephony, Testing, Writing Skills
LOCATION
Holly Springs, NC
POSTED
1 day ago
Payrate: $37.00 - $39.00/hr.
 
Summary:
Ensure compliance with procedures relating to area of responsibilities. Proactive improvement of corporate quality management systems related to microbiology, viral clearance and container closure integrity mechanisms. Resolve bottlenecks related to key changes. Authorship of Operating Standard and SOP revisions. Own GMP materials relating to area of responsibility. Participate in regulatory inspections and site audits as needed.
 
Responsibilities:
  • Receive, inspect, and log samples; verify integrity and documentation.
  • Assign IDs in LIMS and prepare samples for testing (aliquoting, labeling, storage).
  • Chemistry: Perform routine chemical analyses (e.g., potency, purity) using validated methods.
  • Bioassay: Execute cell-based assays and maintain culture integrity for accurate results.
  • Microbiology: PCR testing.
  • Maintain storage areas per SOPs; monitor conditions and perform inventory checks.
  • Complete receipt/disposition forms; ensure GMP/SOP compliance and support audits.
  • Liaise with QC, manufacturing, and labs; manage pickups/deliveries and report issues.
  • Update sample data in LIMS; support process improvements and SOP reviews.
  • Follow safety protocols; keep areas organized and dispose of samples per procedures.
 
Qualifications:
  • BS in Chemistry, Microbiology or Science field. Experience working in a GMP environment/laboratory.
 
Preferred:
  • Biotech or pharmaceutical industry experience.
  • Knowledge of relevant analytical technologies associated with container closure integrity and viral clearance in a pharmaceutical setting.
  • Able to successfully manage workload to timelines.
  • Familiarity with basic project management tools.
  • Strong experience in a laboratory environment.
  • Scientific writing skills.
  • Familiarity with (or ability to learn) SAP, EDMQ and laboratory documentation systems.
 
Top 3 Must Have Skill Sets:
  • Experience in GMP or ISO-regulated environments/laboratory.
  • Basic understanding of quality control testing workflows.
  • -Hands-on experience with LIMS.
 
 
Pay Transparency: The typical base pay for this role across the U.S. is: $37.00 - $39.00 /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. 

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.

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Aditi Consulting

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