Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $38.00 – $40.00/hr.
Summary:
Initial training will occur during the day shift. The ideal candidate will have significant experience in a GMP-regulated lab or manufacturing setting, with expertise in quality records management, including deviations and CAPAs. Proficiency with the Veeva Quality system is highly desirable.
Responsibilities:
- Execute QC second shift activities, collaborating with day and night shift team leads for tasks such as sample receipt, prioritization, and accurate entry into LIMS.
- Act as a point of contact for Manufacturing during night shift operations to support production schedules, resolve issues, and escalate risks.
- Perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as needed.
- Ensure documentation is accurate and compliant with GDP, GMP, and 21 CFR Part 11 requirements.
- Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.
- Utilize electronic systems such as LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS).
- Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.
Qualifications:
- Minimum of 3 years experience in a GMP-regulated Quality Control laboratory.
- Strong background in writing and owning quality records such as deviations and CAPAs.
- Demonstrated ability to work independently in a fast-paced environment with minimal oversight.
Desired Skills:
- Clear written and verbal communication skills.
- Proactive and detail-oriented approach to tasks.
- Experience using the Veeva Quality system.
- Familiarity with electronic systems including LIMS and Biovia.
Pay Transparency: The typical base pay for this role across the U.S. is: $38.00 – $40.00 /hour. 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.
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