Quality Control (QC) Biochemistry Analyst II

Advance Quality in Biotech: Join PDS Tech Commercial as a Quality Control (QC) Biochemistry Analyst II

PDS Tech Commercial is seeking a detail-oriented QC Biochemistry Analyst II to perform routine and advanced biochemistry testing in a fast-paced, FDA-regulated environment. This role is critical to ensuring the quality and compliance of medical devices and diagnostics through precise testing, documentation, and collaboration. If you have a strong background in biochemistry, quality control, and regulated lab environments, we invite you to apply.

Key Responsibilities:

• Perform testing on raw materials, intermediates, finished products, and special requests using techniques such as pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, pO2 Headspace Analysis, and HPLC
• Lead training efforts and serve as a certified trainer for QC testing and instrument maintenance
• Troubleshoot moderate equipment issues and support instrument validation and revalidation
• Document test results in compliance with SOPs, GLP/GMP, and GDP standards
• Support and contribute to Out of Specification (OOS) and INVALID test investigations
• Prepare for internal, customer, and regulatory audits by maintaining lab readiness
• Enter and manage data in LIMS and assist with SOP revisions
• Participate in continuous improvement initiatives and maintain a clean, organized lab environment using 6S principles
• Collaborate with cross-functional teams and assist with validation protocols

Required Qualifications:

• Bachelor’s degree in Biology, Chemistry, or Biochemistry
• OR High School Diploma/GED with ?6 years of experience in a regulated lab environment
• OR Associate’s Degree with ?4 years of experience in a regulated lab environment

Minimum 2 years of experience in QC testing (or equivalent education)

Strong knowledge of biochemistry or chemistry lab techniques and quality principles (GLP/GMP)

Experience with LIMS and technical writing

Familiarity with domestic and international regulations (e.g., ISO, QSR, UL, CSA, VDE)

Experience supporting regulatory audits (FDA, MDSAP, ISO, OSHA, EPA)

Proficiency in interpreting USP and EP/BP method/validation regulations

Skilled in troubleshooting lab instrumentation Preferred Skills:

• Strong organizational and multitasking abilities
• Effective verbal and written communication skills
• Proven problem-solving and leadership capabilities
• Ability to read and execute SOPs and assess safety/environmental risks

Why Join Us?

At PDS Tech Commercial, you’ll be part of a team that ensures product integrity and regulatory compliance in the biotech and medical device industry.

• Company Culture: Quality-focused, collaborative, and innovation-driven
• Pay Rate: $40.18/hour

Ready to Apply?

If you’re a skilled biochemistry professional ready to contribute to high-impact quality initiatives, apply today to join PDS Tech Commercial and help advance healthcare innovation.

Pay Details: $40.18 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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