QC Associate II # 26-19127

Creative Solutions Services, LLC; Fremont (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Fremont, CA seeks a QC Analyst for a 06 months contract. The role covers routine and non-routine testing in a high‑purity QC laboratory across drug substance and drug product productions.

The ideal candidate has 3–5 years GMP experience, strong communication, and the ability to work independently or in teams while upholding cGMP compliance.

Qualifications

• Requires Bachelors' degree in Biology or Life Sciences.
• 3-5 years of GMP experience is highly preferred.
• Strong communication skills, written and oral.
• Ability to work independently and as part of a team to meet goals.
• Comfort interacting with multiple departments and levels.

Responsibilities

• Provide expertise on routine and non-routine testing in QC laboratories in a multi-product facility.
• Perform technical review, interpretation, trending, quality review and investigation of atypical results.
• Assist with quality risk assessments, onboarding, qualification and validation activities for non-routine equipment.
• Suggest process improvements and new approaches to lab processes and compliance.
• Lead cross-functional teams on complex QC compliance deliverables across deviations, investigations, CAPAs and change controls.
• Support audits and inspections as needed.
• Work with basic biochemistry and drug product testing concepts (UV-vis, Osmolality, Microbiology).
• Document results according to cGMP and cGDP, escalate abnormalities promptly.

Skills

GMP Experience

Interpersonal Skills

Customer Focus

Independent Worker

Cross-functional

Attention to Detail

LIMS

Veeva

GoTrack

Education

Bachelor's degree in Biology or Life Sciences

Tools

LIMS

Veeva

GoTrack

Job description

Duration: 06 Months Contract Schedule Notes: 1st Shift: Mon-Fri, 9:00AM-5:00PM

Duties

• Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility.
• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
• Assist with quality risk assessments, onboarding, qualification and implementation of non-routine, new equipment validation activities.
• Assist with implementing novel improvements and new ways of thinking toward lab processes and compliance activities.
• Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).
• Provide support during audits and inspections.
• Work independently with adequate training and background of fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, Osmolality, Microbiology and more.
• Review of analytical results within timeline right the first time.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains own training within compliance and assist other technicians and associates on operations upon completion of trainer qualification.
• Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments

Skills

• 3-5 years of industry experience GMP experience is highly preferred
• Demonstrates strong interpersonal and communication skills (both written and oral)
• Strong customer focus, and an ability to interact with various departments and levels.
• Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals
• Able to work across functions to achieve common goals.
• Demonstrates strong attention to detail, and an ability to focus on details of execution.
• System familiarity that would be helpful: LIMS, Veeva & GoTrack

Education

• Bachelors' degree in Biology or Life Sciences required.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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