QC Engineer II
Job
Actalent
Saint Louis, MO (In Person)
$75,920 Salary, Full-Time
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Job Description
Job Title:
QC Engineer II Job Description As a QC Engineer II, you will execute Global Trackwise (GTW) tasks for Quality Records, including CAPAs, Action Items, and Impact Assessments. You will also handle eDMS tasks related to SOPs, JA, WI, Training Documents, and client sampling plans. You will represent QCSM/LS in cross-functional tasks, meetings, and projects as needed, and monitor departmental metrics and standard work. Additionally, you will coordinate and schedule stability sets and pulls per the stability MPS, manage stability paperwork in the eDMS system, and leverage PPI systems and LIMS capabilities to improve the visibility and management of samples, standards, and other QC items in storage. You will participate in strategic QC process improvements as assigned by management and perform other job duties as needed. Responsibilities Execute Global Trackwise (GTW) tasks forQuality Records:
CAPAs, Action Items, Impact Assessments. Perform eDMS tasks related to SOPs, JA, WI, Training Documents, client sampling plans. Represent QCSM/LS in cross-functional tasks, meetings, and projects. Monitor departmental metrics and standard work processes. Coordinate and schedule stability sets and pulls according to stability MPS. Manage stability paperwork in the eDMS system. Leverage PPI systems and LIMS capabilities for better management of samples and QC items. Participate in strategic QC process improvements as assigned by management. Perform additional job duties as assigned. Essential Skills Quality assurance and quality control expertise. Experience in sample preparation and sample management. Proficiency in lab preparation. Intermediate to advanced skills inMicrosoft Office Applications:
Word, Excel, PowerPoint, Teams, OneNote, and Project. Experience with SmartSheet and/or PowerBI. Excellent time management and task prioritization skills. Ability to work independently and self-manage tasks and deliverables. Strong conceptual and communication skills regarding inventory process flows in a QC Lab Environment. Understanding of customer requirements related to Quality control in inventory and capacity planning. Strong interpersonal skills with active listening, conflict resolution, and stakeholder influence abilities. Highly organized with strong attention to detail. Familiarity with project management concepts and tools. Additional Skills & Qualifications High School Diploma required; higher education is a plus. At least five years of experience in the medical, pharmaceutical, or regulated industry. Experience managing sample, standard, and stability study inventory is advantageous. Experience in writing deviation investigations, root cause analysis, and CAPA planning. Familiarity with LIMS systems or similar inventory management systems. Experience in independent roles or leadership roles such as team lead or supervisor is a plus. Work Environment The role involves a Monday to Friday schedule with an 8-hour shift from 8am to 4pm. Candidates should be comfortable working on computers with various systems, software, and Excel. Job Type & Location This is a Contract to Hire position based out of St. Louis, MO. Pay and Benefits The pay range for this position is $35.00 - $38.00/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 St.
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