QC Expert

Aequor; Carlsbad (CA); In loco; USD 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

HireLifeScience in Carlsbad, California seeks a QC Expert for a 6-month onsite assignment. The role focuses on testing materials and products using chemistry lab methods, ensuring SOPs, analytical methods, and compendia are followed.

The ideal candidate has 3–5 years of GMP/QC laboratory experience, hands-on HPLC/UPLC, data integrity practices, and familiarity with cGxP standards. Radioactive materials handling is part of the environment; safety and documentation are essential.

Competenze

• 3–5 years experience in a GMP testing laboratory environment.
• Experience with cGMP and QC microbiology.
• Knowledge of HPLC/UPLC and analytical methods.
• Ability to ensure data integrity and SOP compliance.
• Note: exposure to radioactive materials and hazardous chemicals.

Mansioni

• Ensure all activities comply with cGxP, including data integrity review and analytical data approval.
• Review and approval of analytical tests (analytical release).
• Carry out microbiological QC and environmental monitoring.
• Support sample planning and sampling execution.
• Report technical complaints/adverse events within 24 hours of receipt.
• Maintain meticulous documentation and laboratory records.

Conoscenze

HPLC/UPLC

cGxP

Data integrity

Microbiology

GMP

Formazione

Bachelor's degree in life sciences

Strumenti

Empower software

Descrizione del lavoro

Job Title: QC Expert

Duration: 6 months

Location: Carlsbad, California (Onsite)

Shift: Shift hours are expected to be 8AM to 8PM {Sunday to Tuesday and every other Wednesday} OR {Every other Wednesday and Thursday to Saturday}. Periodic mandatory overtime may be necessary to ensure process continuity and completion.

Pay Rate: *** - ***

Job Description:

This role utilizes chemistry laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods and current Compendia.

Major Accountabilities:

• Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release)
• Review and approval of analytical tests (analytical release)
• HPLC/UPLC (Empower software experience preferred)
• Microbiological QC, Perform Microbiological testing of materials and utilities, environmental and personnel monitoring -Provide expert Support for site qualification and validation activities
• Support sample planning and sampling execution
• Reporting technical complaints / adverse events / special case scenarios related to *** products within 24 hours of receipt
• Individuals should have a good general understanding of chemistry and microbiological laboratory concepts and practices.

Key Performance Indicators:

• Timely completion of training
• Timely and GMP-compliant analysis & documentation of the results
• Error rate: Number of OOS (analysis errors) related to the number of analyses

Work Experience:

• 3-5 years experience in a GMP testing laboratory environment.
• Good Manufacturing Practices (cGMP)
• Quality Control
• Quality Management Systems
• Technological Expertise
• Quality Control Microbiology
• Laboratory Excellence
• Documentation Management
• Quality Compliance

Skills & Education:

• B.S. in the life sciences (Chemistry, Microbiology) or related field
• Problem Solving Skills
• Communication skills
• Data Integrity

Note: The external will be working with Radioactive materials, chemicals and dealing with various microorganisms.