Quality Assurance Associate
AL Solutions · San Diego, California, United States
FULL TIME
Job Description
QC Associate I / II (Contract)Quality Control | Biologics | GMP EnvironmentAre you a detail-oriented laboratory professional with experience in biologics testing and GMP-regulated environments? We are seeking a QC Associate I or II to join a growing Quality Control team, supporting analytical testing, method transfers, validation activities, and release testing for biologic products.This is an excellent opportunity to contribute to the development and manufacture of innovative biologics while working within a highly collaborative, quality-focused environment.
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
The OpportunityAs a QC Associate I / II, you will perform analytical testing and laboratory activities supporting stability programs, method qualifications, validations, and product release testing. You will play a key role in maintaining compliance with cGMP, GDP, ALCOA+ data integrity principles, and global regulatory standards while ensuring laboratory inspection readiness.Working closely with Quality Assurance, Analytical Development, Manufacturing, MSAT, and other cross-functional teams, you will help drive quality, compliance, and operational excellence across QC operations.
Role overviewEmployment type: ContractLength: 6-months with a view to extend or go permanentHours: Full-timeWorking model: On-site in San DiegoPayment options: W2 or 1099
Key ResponsibilitiesAnalytical Testing & Laboratory OperationsPerform routine and non-routine testing of:In-process samplesRelease samplesStability samplesRaw materialsReference standardsInvestigational materialsExecute analytical methods for biologics and large molecule products using:HPLC/UHPLCCE-SDScIEF/icIEFELISAUV-Vis SpectroscopyCompendial methodsAdditional biochemical and physicochemical techniquesComplete testing accurately and within established timelines.Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and data integrity requirements.Support method transfer, method qualification, verification, and validation activities.
Data Review & DocumentationPerform first-person review of analytical data.Prepare and review:Certificates of Analysis (CoA)Stability Summary Sheets (SSS)Analytical reportsMethod qualification reportsValidation reportsTechnical documentationEnsure all documentation remains complete, attributable, contemporaneous, and inspection-ready.
Compliance & Continuous ImprovementParticipate in laboratory investigations including:OOS (Out of Specification)OOT (Out of Trend)Invalid result investigationsSupport internal audits, client audits, and regulatory inspections.Assist with equipment maintenance and qualification activities.Contribute to process improvement initiatives and implementation of new technologies.Identify and escalate compliance or data integrity concerns.
What We're Looking ForEducationBachelor's degree in:BiologyBiochemistryChemistryBiotechnologyPharmaceutical SciencesOr a related scientific discipline
ExperienceQC Associate I0-3 years of laboratory experience within biotechnology, pharmaceutical, or related industries.
QC Associate II3-6+ years of experience in a GMP-regulated Quality Control laboratory environment.
Technical SkillsExperience with one or more of the following is highly desirable:HPLC/UHPLCCE-SDSELISAcIEF/icIEFUV-VisStability testingGMP documentationMethod transfer and validationData integrity and ALCOA+ principlesLIMS systems (preferred)
Ideal CandidateYou are:Highly organized and detail-orientedPassionate about quality and complianceComfortable working in a fast-paced GMP environmentExperienced in biologics or large-molecule analytical testingA collaborative team player with strong communication skillsCommitted to maintaining inspection readiness and data integrity
Physical RequirementsAbility to stand and walk for extended periods.Frequently lift and/or move objects up to 20 lbs.Ability to use hands and arms for laboratory activities.Ability to bend, kneel, crouch, balance, and reach as required. xzbcwsv Strong visual acuity, including color vision and depth perception.
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
The OpportunityAs a QC Associate I / II, you will perform analytical testing and laboratory activities supporting stability programs, method qualifications, validations, and product release testing. You will play a key role in maintaining compliance with cGMP, GDP, ALCOA+ data integrity principles, and global regulatory standards while ensuring laboratory inspection readiness.Working closely with Quality Assurance, Analytical Development, Manufacturing, MSAT, and other cross-functional teams, you will help drive quality, compliance, and operational excellence across QC operations.
Role overviewEmployment type: ContractLength: 6-months with a view to extend or go permanentHours: Full-timeWorking model: On-site in San DiegoPayment options: W2 or 1099
Key ResponsibilitiesAnalytical Testing & Laboratory OperationsPerform routine and non-routine testing of:In-process samplesRelease samplesStability samplesRaw materialsReference standardsInvestigational materialsExecute analytical methods for biologics and large molecule products using:HPLC/UHPLCCE-SDScIEF/icIEFELISAUV-Vis SpectroscopyCompendial methodsAdditional biochemical and physicochemical techniquesComplete testing accurately and within established timelines.Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and data integrity requirements.Support method transfer, method qualification, verification, and validation activities.
Data Review & DocumentationPerform first-person review of analytical data.Prepare and review:Certificates of Analysis (CoA)Stability Summary Sheets (SSS)Analytical reportsMethod qualification reportsValidation reportsTechnical documentationEnsure all documentation remains complete, attributable, contemporaneous, and inspection-ready.
Compliance & Continuous ImprovementParticipate in laboratory investigations including:OOS (Out of Specification)OOT (Out of Trend)Invalid result investigationsSupport internal audits, client audits, and regulatory inspections.Assist with equipment maintenance and qualification activities.Contribute to process improvement initiatives and implementation of new technologies.Identify and escalate compliance or data integrity concerns.
What We're Looking ForEducationBachelor's degree in:BiologyBiochemistryChemistryBiotechnologyPharmaceutical SciencesOr a related scientific discipline
ExperienceQC Associate I0-3 years of laboratory experience within biotechnology, pharmaceutical, or related industries.
QC Associate II3-6+ years of experience in a GMP-regulated Quality Control laboratory environment.
Technical SkillsExperience with one or more of the following is highly desirable:HPLC/UHPLCCE-SDSELISAcIEF/icIEFUV-VisStability testingGMP documentationMethod transfer and validationData integrity and ALCOA+ principlesLIMS systems (preferred)
Ideal CandidateYou are:Highly organized and detail-orientedPassionate about quality and complianceComfortable working in a fast-paced GMP environmentExperienced in biologics or large-molecule analytical testingA collaborative team player with strong communication skillsCommitted to maintaining inspection readiness and data integrity
Physical RequirementsAbility to stand and walk for extended periods.Frequently lift and/or move objects up to 20 lbs.Ability to use hands and arms for laboratory activities.Ability to bend, kneel, crouch, balance, and reach as required. xzbcwsv Strong visual acuity, including color vision and depth perception.