Quality Control Analyst I

Job Description

Quality Control Analyst I | AllSTEM Connections

The Tone:
This is a contract role at a client of AllSTEM Connections, located in Camarillo, CA. The client operates a quality control laboratory, integral to the pharmaceutical or biotech industry, focusing on product development and manufacturing. This position is essential for ensuring that in-process, finished products, and stability samples meet stringent quality standards and regulatory requirements through diligent testing and meticulous documentation. The role directly contributes to the integrity and safety of products, upholding compliance within a regulated environment.

The TL;DR
• Role: Contract / Early Career
• Type: Full-time (Standard Shift)
• Location: In-person, Camarillo, CA
• Pay: $41 hourly
• Mission: To ensure accurate product testing and regulatory compliance through precise laboratory work and comprehensive documentation within a Quality Control laboratory.
• Tech Stack: pH, Osmolality, FT-IR, analytical balances, micropipettes, HPLC (exposure), ICH, USP, 21CFR Part 210, 211, ALCOA+

What You’ll Actually Do
• Conduct routine laboratory testing on in-process, finished product, and stability samples, utilizing instruments such as pH meters, Osmometers, and FT-IR, to ensure product specifications are met.
• Oversee comprehensive sample management activities, including meticulous login, precise labeling, diligent tracking, secure storage, and efficient coordination of internal and external shipments, ensuring sample integrity.
• Execute the stability program by performing scheduled sample pulls, preparing submissions for analytical testing, maintaining accurate inventory records, and diligently tracking all related activities for long-term product assessment.
• Ensure all documentation and data recording meet rigorous quality standards, adhering strictly to current Good Manufacturing Practices (cGMP), ALCOA+ principles, and all data integrity requirements for audit readiness.
• Provide direct support for laboratory investigations into quality events, such as comprehensive analysis of out-of-specification (OOS) results, deviations, and invalid assays, contributing to root cause analysis.

The Must-Haves
• Background: Bachelor’s Degree in a related scientific field. This is an entry-level position suitable for recent graduates or those with limited initial experience.
• Experience: Requires 1–2 years of hands-on laboratory experience. Prior experience specifically within a GMP (Good Manufacturing Practice) Quality Control laboratory or the pharmaceutical industry is highly preferred.
• Skills: Demonstrates strong attention to detail and exceptional organizational capabilities for managing laboratory tasks and documentation. Possesses the ability to accurately follow complex instructions and adhere strictly to cGMP procedures and approved Standard Operating Procedures (SOPs) with minimal supervision. Exhibits robust time management skills, capable of supporting multiple priorities simultaneously, and comfortable performing routine and repetitive laboratory and documentation activities.
• Bonus: Basic exposure to analytical instruments such as HPLC, pH meters, Density meters, Osmolality meters, FT-IR, analytical balances, or micropipettes. Familiarity with regulatory guidelines including ICH, USP, 21CFR Part 210, and 211 is also preferred.