Quality Control Analyst, Sample Management
Job
Actalent
Vacaville, CA (In Person)
$67,600 Salary, Full-Time
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Job Description
Job Title:
Quality Control Analyst, Sample Management As a Quality Control Analyst in Sample Management, you will play a critical role in maintaining the lifecycle of quality control samples. This includes ensuring accurate receipt, labeling, aliquoting, storage, distribution, and disposal of samples in compliance with regulatory and company standards. You will support laboratory operations by maintaining sample inventory systems, preparing samples for testing, and ensuring proper documentation and traceability. Collaboration with QC laboratories, manufacturing, and logistics teams is essential to ensure timely sample availability while adhering to Good Manufacturing Practices (GMP) and data integrity requirements. Responsibilities Receive, log, and label incoming samples in accordance with SOPs and regulatory requirements. Maintain accurate sample tracking using paper-based logs and electronic systems such as LIMS. Ensure proper storage of samples, including temperature-controlled environments and stability chambers. Coordinate sample distribution to QC laboratories for testing. Monitor critical reagent and reference standard inventory levels. Manage the sample lifecycle from receipt through disposal. Prepare and aliquot samples for testing while maintaining the chain of custody. Ensure compliance with GMP, GDP, and data integrity standards. Review and verify sample-related documentation and equipment logbooks for accuracy and completeness. Support stability studies by managing sample pulls and tracking time points. Coordinate with manufacturing and logistics teams for sample requests and timelines. Perform biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. Assist with SOP creation, revision, and training related to sample management processes. Identify and contribute to deviation and laboratory investigations, including sample discrepancies andOOS/OOE/OOT
events. Maintain the laboratory in an inspection-ready state. Hold self and others accountable to abide by department and company policies and practices. Adhere to cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements. Perform sampling and testing of incoming raw materials. Essential Skills Experience maintaining cGMP compliant Quality Control and Stability laboratories. Ability to follow written instructions and perform tasks with direct or minimal supervision. Capability to work independently as well as in a team environment. Familiarity with Laboratory Information Management Systems (LIMS). Proficient in using computers, including Windows, Microsoft Word, and Excel. Strong written and verbal communication skills. Strong documentation skills are essential. Additional Skills & QualificationsB.S./B.A./A.A.
in Science or a related field such as biology, biochemistry, or chemistry. Minimum of 2 years of relevant laboratory experience in a GMP environment is desired. Work Environment The position requires the ability to occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and the ability to adjust focus. The work environment involves maintaining GMP operations in a Quality Control laboratory, ensuring adherence to Good Documentation Practices, proper sample handling, and chain of custody. The role requires compliance with Standard Operating Procedures and an understanding of regulatory requirements, with proficiency in using LIMS and supporting inspections and quality audits. Job Type & Location This is a Contract to Hire position based out of Vacaville, CA. Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Vacaville,CA.
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