Sr. Associate, QC Micro

Theragent Inc.; Arcadia (CA); On-site; USD 41,000 - 55,000; Full time

Job summary

Theragent Inc. in Arcadia, CA is seeking a Senior Associate, QC Micro to help build and operate a CGMP-compliant QC Microbiology laboratory for cell and gene therapy products.

You will perform environmental monitoring, microbiological testing, and support for lot release, stability, and in-process samples, while ensuring precise documentation and regulatory compliance. The role requires strong microbiology knowledge, experience with CGMP and ICH guidelines, and ability to manage multiple tasks

Qualifications

• Knowledge of CGMP, ICH, pharmacopoeia and regulatory requirements for testing in the pharmaceutical industry is required.
• Experience in qualification of cell therapy equipment is preferred.
• Working knowledge of deviations, change controls and CAPAs.
• Basic knowledge of compendial requirements (USP/EP/JP) and related standards.

Responsibilities

• Perform environmental and utility monitoring of the CGMP facility under full gowning.
• Read plates, count colonies, and document results; review data with Lab Associate.
• Perform microbiology assays including bioburden and endotoxin testing.
• Support quarterly and annual reports, trend investigations, and quality statements.
• Assist with the qualification of lab equipment and GMP software systems.
• Assist in drafting SOPs, test methods, validations and deviations.

Skills

CGMP knowledge

ICH guidelines

Deviations/Change Controls

Documentation skills

Microbiology knowledge

Environmental monitoring

Aseptic processing

LIMS experience

MS Office

Communication skills

Education

Bachelor's degree in Microbiology

Tools

LIMS

Microbiology equipment

Microsoft Office

Job description

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Sr. Associate, QC Micro

Quality Full Time Arcadia, CA, US

Salary Range: $30.00 To $40.00 Hourly

Position Summary:

The Senior Associate, QC Micro has a unique opportunity to play a key role in building of the QC Microbiology laboratory from ground up for a Cell and Gene therapy biotech startup. The Senior Associate, QC Micro will be responsible for participating in the day-to-day operation of CGMP compliant Quality Control Microbiology laboratory of Theragent Inc to include performing and providing support for functional aspects of the facility such as environmental and utility monitoring (EM), microbiological testing, media fills, water testing, and other activities that will support execution of testing for CGMP samples for in-process, lot release and stability samples in-house. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and CGMP regulations. The QC Microbiology Laboratory is a highly controlled environment, where significant attention must be paid to written procedures, safety, and CGMP compliance. Schedules and completing testing on time error free are of paramount importance. The lab is equipped with highly sensitive and expensive instruments which must be handled with care.

Primary Responsibilities:

• Performenvironmentalandutilitymonitoringofthecellandgenetherapyproductionfacilityaccordingto written procedures while fully gowned including operationalmonitoring and personnel monitoring during aseptic processing, and aseptic filling. Perform routine environmental monitoring, as needed to meet schedules.
• Read environmental and utility monitoring plates by counting microbial colonies. Fill out appropriate reports and forms contemporaneously and review data provided by Lab Associate. Perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with CGMP regulations.
• Perform other microbiology assays, including bioburden, endotoxin, etc.
• Supportpreparationofquarterlyandannualreports,trendinvestigations,statementsof quality, and other applicable reports.
• SupportonboardingandqualificationoflaboratoryequipmentandGMPsoftwaresystems.
• AssistwiththegenerationofSOPsrelatedtotestmethodsandproductlotrelease.
• Assistindraftingtechnicaldocumentsincludingtestmethods,validationdocuments,anddeviations.
• Purchase all necessary supplies, needed for QC Microbiology and receive supplies, log-in and store appropriately following written procedures.
• Performgrowthpromotionanalysesonallmicrobiological media lots received. Report results on appropriate forms and review results of Lab Associate.
• Perform laboratory and equipment cleaning, preventative maintenance and calibrationon a regular basisas described in written procedures. Recordallnecessaryinformationandmaintaincurrent,accurate, legible records of all work performed. Report problems to management.
• Ensurecompliancewithallqualityrequirementstomeetauditstandardsandregulatorycompliance.
• Maintainlabequipment,reagentsinventory,anddocumentationtoensureaccurate,timely,andcost- effective analysis of materials and products.
• AssistintrainingstaffonmethodsandrelatedSOPs.
• Analyzeandsummarizedataintoreportswithattentiontodetails.
• Supportanyimprovementsidentifiedthroughinvestigationsandaudits.
• Performsamplemanagementtasks,includinglabeling,shippingtoexternallabs,inventory,and disposal of samples.
• Other duties as assigned by management.

Reports to: Supervisor, QC Microbiology

FLSA Status:Non-exempt

Knowledge, Skills & Abilities:

• KnowledgeofCGMP,ICH,pharmacopoeia,andregulatoryrequirementsfortestingpertainingtothe pharmaceutical industry is required.
• Experienceinthequalificationofcelltherapyequipmentaplus.
• Knowledgeofpharmaceutical,manufacturingandlaboratorysystemsandequipment.
• WorkingknowledgeofDeviations,ChangeControls,andCAPAs.
• BasicknowledgeofCompendial(i.e.,USP,EP,JP,etc.)requirementsandstandards.
• StrongknowledgeofCGMPandICHguidelines.Otherregulatoryagenciesexperiencespreferred.
• StrongunderstandingofMicrobiologyrelatedtodrugsubstanceordrugproductmanufacturing.
• Strongwrittenandverbalcommunicationskills.
• Excellentinterpersonalandteamworkskillswithexperiencedealingwithalllevelswithinthecompany.
• Willingness to collaborate internally and with clients while following regulations
• Strong multi-tasking ability in conjunction with proven organizational and record keeping skills.
• Abilitytoorganizeassignedtasksinahighpacedenvironmentandmonitortasks/assignments that may impact timely completion.
• Abilitytoeffectivelymanagemultipletasksandactivitiessimultaneously.
• Proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Strong team player, able to meet deadlines and change priorities.

Education & Professional Experience:

• Bachelor’s degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be considered.
• Atleast4yearsofworkexperienceinthePharmaceutical,LifeSciencesindustrywithCGMP,GLP.
• ExperiencewithproblemsolvingmethodssuchasDMAICorothersimilarRootCauseAnalysisTools.
• ExperiencewithelectronicLaboratoryInformationManagementSystems(LIMS).
• Experience with relevant microbiology laboratory equipment and software.

Working Conditions:

• Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Clean room Manufacturing and Laboratory environment
• Must be able to read, write, and converse in English
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
• Ability to sit, stand, walk and move within workspace for extended periods.
• Ability to perform repetitivetasks including hand to finger manipulations, grasping, pushingand pulling.
• Ability to work safely and effectively when working alone or working with others.

Travel:Occasional. Less than 10%

Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.

Theragent, Inc requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID- 19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.