QC Associate II

Spectraforce Technologies; Fremont (CA); On-site; USD 62,000 - 78,000; Full time

Job summary

Spectraforce Technologies in Fremont, CA seeks a QC Associate II to join the Phys-Chem Testing team. The role focuses on executing routine and non-routine testing of bulk drug substances, final products, and raw materials in a multi-product facility.

Perform UV-Vis, QPCR, FTIR analyses; maintain inventory; document results in cGMP/cGDP compliant records; support investigations and deviations; ensure safety.

Qualifications

• 3–5 years of industry experience.
• GMP experience preferred.
• Technical skills: UV-Vis absorbance, QPCR, FTIR.
• Strong interpersonal and communication skills (written and oral).
• Strong customer focus and ability to interact with multiple departments.
• Ability to work independently and as part of a team; meet goals.
• Able to work cross-functionally to achieve common goals.
• Strong attention to detail.

Responsibilities

• Execute and coordinate routine and non-routine testing of bulk drug substance, final finish products, and raw materials within a multi-product facility.
• Perform laboratory operations independently following training; include UV-Vis, QPCR, FTIR, and compendial testing.
• Maintain inventory of consumables and materials; dispose of expired reagents; report anomalies.
• Deliver high-quality analytical results within timelines; ensure accuracy 'right first time'.
• Document all work in compliance with cGMP and cGDP."
• Adhere to site procedures, regulatory standards, and quality systems.
• Report deviations, abnormalities, or out-of-spec results.
• Maintain safety; escalate unsafe conditions.
• Maintain 5S and cleanliness in lab spaces.
• Ensure personal training is current and compliant.

Skills

Interpersonal skills

Communication skills

Teamwork

Attention to detail

Education

Bachelor's degree in Biology or Life Sciences

Tools

UV-Vis absorbance

QPCR

FTIR

Job description

.Position Title: QC Associate II

Work Location: Fremont, CA 94555

Assignment Duration: 6 Months

Work Schedule: 1st Shift: Mon-Fri, 8:00AM-5:00PM

As part of the QC Phys-Chem Testing team, execute and coordinate routine and non-routine testing of bulk drug substance, final finish products, and raw materials within a multi-product facility.

Key Responsibilities:

• As part of the QC Phys-Chem Testing team, execute and coordinate routine and non-routine testing of bulk drug substance, final finish products, and raw materials within a multi-product facility.
• Perform laboratory operations independently following appropriate training, including but not limited to: UV-Vis absorbance, QPCR, FTIR and compendial testing.
• Perform essential laboratory support activities such as maintaining inventory of consumables and materials, properly disposing of expired reagents, and identifying and reporting process or equipment anomalies.
• Deliver high-quality analytical results within established timelines, ensuring accuracy "right first time."
• Accurately document all work in compliance with cGMP and cGDP requirements.
• Adhere to all site-specific procedures, regulatory standards, and quality systems.
• Promptly and accurately report deviations, abnormalities, or out-of-specification results.
• Maintain strict adherence to safety standards by recognizing and escalating unsafe conditions or behaviors.
• Maintain laboratory workspaces in accordance with established 5S and cleanliness standards.
• Ensure personal training is current and compliant with all regulatory and organizational requirements.

Qualification & Experience:

• 3-5 years of industry experience
• GMP experience is preferred.
• Technical skills preferred: UV-Vis absorbance, QPCR, and FTIR.
• Strong interpersonal and communication skills (both written and oral)
• Strong customer focus, and an ability to interact with various departments and levels.
• Ability to work independently and as part of a team, to meet departmental/facility goals
• Able to work across functions to achieve common goals.
• Strong attention to detail, and an ability to focus on details of execution.
• Bachelors' degree in Biology or Life Sciences required