QA Support Intern

Job Summary

Provide supervised, office-based support to the Quality Assurance team through archive organization, document readiness activities, checklist-based pre-review support, binder completeness verification, reporting support, and administrative QA tasks. The role is structured to provide practical exposure to pharmaceutical quality systems while maintaining no independent GMP decision-making authority. The QA Support Intern supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

Archive space-saving and document organization

• Move eligible archived documents from large binders into smaller binders using a preapproved transfer method and indexing convention.
• Update binder spine labels, contents sheets, and archive location logs.
• Create before/after cabinet capacity records to support a repeatable space-saving practice.
• Maintain a transfer log so QA can trace where each document set was moved.

Archive indexing and retrieval readiness

• Build or update archive inventories, metadata sheets, and retrieval maps.
• Standardize naming conventions and flag duplicate, obsolete, or difficult-to-retrieve files for supervisor review.
• Prepare an archive quick-reference guide for future retrieval and filing consistency.

Work order pre-review support

• Review completed work orders against a QA-prepared checklist for presence, legibility, signatures/initials, dates, attachments, and obvious inconsistencies.
• Record observations on a separate review sheet without marking the original work order.
• Sort findings by type so the qualified reviewer can focus quickly on likely issues.
• Prepare work orders in organized review batches for Vasantha or other assigned QA staff.

IOPQ equipment binder routine review support

• Review IOPQ binders using a standard completeness checklist.
• Check whether expected sections, protocols, reports, approvals, attachments, traceability items, and referenced forms are present.
• Flag missing or inconsistent content on a separate checklist.
• Perform routine verification against open deviations, linked actions, and assigned CAPA-related follow-up items where this has been predefined by QA.
• Prepare a summary sheet showing what is present, what is missing, and what requires qualified QA assessment.

QC IOPQ equipment binder routine review support

• Apply the same checklist-based review model to QC binders.
• Check section completeness, document order, signatures, dates, attachments, referenced worksheets/results, and filing consistency.
• Flag missing or mismatched items without writing on original GMP records.
• Cross-check predefined items against open deviations and applicable follow-up actions when assigned by QA.
• Prepare QC binder summary sheets for qualified reviewer follow-up.

Metrics and reporting support

• Maintain weekly progress trackers for binders reviewed, archive volumes reduced, issues logged for QA review, and training aids drafted.
• Prepare simple summary dashboards or status sheets from approved data sets.
• Support end-of-internship reporting with before/after examples and quantified outputs.

General Office Support – QA and general Operations

• Provide support as needed (scan/organization) to office work in QA and other teams (ie COO, Manufacturing, etc).

Required Knowledge, Skills and Abilities

• Strong attention to detail and organizational skills.
• Ability to follow SOPs, checklists, and documented processes.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Written and verbal communication skills
• Ability to handle confidential information
• Basic understanding of document control principles preferred
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Education and Experience Requirements

Current high school, undergraduate or graduate students with interest in Life Sciences, Pharmacy, Biotechnology, Quality, Engineering, or related discipline.

Physical Demands

N/A

Working Conditions

Office based position

Certificates & Licenses Required

N/A

Compensation

$16-$20 per hour

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No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

Scientist/ Senior Scientist, In vitro & Preclinical Translational Research

Job Summary

We are seeking a highly motivated Scientist/Senior Scientist with strong expertise in both in vitro and in vivo translational studies for preclinical and IND-enabling research programs. This role is ideal for a PhD-level/ Masters level scientist with strong hands-on laboratory experience and a working understanding of animal research supported translational studies, particularly in oncology, biologics, or antibody-drug conjugates (ADCs). The incumbent works cross-functionally with internal departments and external resources on in vitro and in vivo translational research related issues. The Scientist/ Senior Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Design, execute, and analyze cell based and biochemical assays to evaluate target biology, mechanism of action, and compound/biologic efficacy.
• Support and/or conduct rodent (mouse) in vivo studies in compliance with IACUC and institutional guidelines.
• Perform mouse handling, dosing (e.g., IV, IP, SC, PO injections), blood collection, tissue harvesting, and necropsy.
• Assist with study planning, execution, and data analysis for pharmacology, efficacy, PK/PD, and tolerability studies.
• Document study outcomes and contribute to study reports, presentations, and regulatory supporting materials.
• Maintain accurate experimental records and analyze datasets using appropriate statistical methods.
• Troubleshoot assays and contribute to continuous method improvement.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Proven ability to design experiments, analyze data, and communicate results clearly
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Education and Experience Requirements

Required:

• PhD in Biology, Biotechnology, Biomedical Sciences, Pharmacology, or a related field with 2+ years (Scientist) or 4+ years (Senior Scientist) of related industry experience

OR

• Master’s/bachelor’s degree in biology, Biotechnology, Biomedical Sciences, Pharmacology, or related field with 6-8 years of equivalent hands on experience.
• Strong hands on experience with in vitro cell culture and assay development.
• Hands on experience supporting or conducting in vivo mouse studies, including handling, injections/dosing, and sample collection.
• Experience working in a preclinical, translational, CRO, biotech, or pharmaceutical environment.

Preferred:

• Demonstrated experience in oncology, biologics, or antibody drug conjugates (ADCs).
• Experience with flow cytometry, ELISA/Luminex, imaging based assays, or multi parameter data analysis.
• Prior involvement in IND enabling or regulatory facing studies.
• CRO management or sponsor facing experience.
• Familiarity with GLP/GxP considerations and preclinical regulatory expectations.

Physical Demands

N/A

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

N/A

Compensation

Scientist: $55,000 to $75,000 per annum

Senior Scientist: $88,000 to $110,000 per annum

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*We kindly request that agencies and recruiters do not contact us regarding this position.

Vivarium/ Animal Care Technician

Job Summary

We are seeking a motivated Vivarium/ Animal Care Technician to support preclinical and translational research studies. This role involves hands-on animal care, maintaining accurate records, ensuring clean animal facilities. The incumbent works cross-functionally with internal departments and external resources on such related issues. The Vivarium/ Animal Care Technician supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Daily husbandry of laboratory rodents (primarily mice and rats), including:
  Feeding, watering, cage changing, and sanitation.
• Maintaining accurate animal care and vivarium records.
• Cleaning and maintaining animal rooms, equipment, and work areas.
• Following all IACUC, institutional, and safety protocols.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Ability to follow SOPs and regulatory requirements.
• Comfortable handling mice and rats.
• Strong attention to detail and willingness to follow strict protocols.
• Reliable, punctual, and responsible
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Flexibility to work on a rotational weekly-off schedule, including mandatory weekend work as required by business needs.

Education and Experience Requirements

Required:

• High school diploma
• 1–2 years of experience in laboratory animal care (rodents required)

Preferred:

• Experience working in an academic or research vivarium.
• Familiarity with basic animal health indicators.
• IACUC or institutional animal care training (or willingness to complete training)

Physical Demands

N/A

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

N/A

Compensation

$28 to $30 per hour

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*We kindly request that agencies and recruiters do not contact us regarding this position.

In vivo Lab Technician, Preclinical Research

Job Summary

We are seeking a motivated In vivo Lab Technician to support preclinical and translational research studies. This role involves hands-on animal care and technical support for in vivo pharmacology, toxicology, and disease models. Candidates with ALAT certification are preferred. The incumbent works cross-functionally with internal departments and external resources on preclinical and translational research related issues. The In vivo Lab Technician supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Perform daily animal husbandry, health checks, and cage maintenance.
• Assist with in vivo study execution including dosing (IV, IP, SC, PO), animal monitoring, and data collection.
• Support blood, tissue, and organ sample collection under supervision.
• Maintain accurate animal records and study documentation.
• Ensure compliance with IACUC protocols, AAALAC standards, and animal welfare regulations.
• Assist with vivarium maintenance and sanitation procedures.
• Work closely with scientists and veterinary staff to support study timelines.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Ability to follow SOPs and regulatory requirements.
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Education and Experience Requirements

Required:

• Associate’s or Bachelor’s degree in Biology, Animal Science, or related field (or equivalent experience).
• Hands-on experience working with laboratory animals (rodents preferred).
• Strong attention to detail and record-keeping skills.

Preferred:

• Experience with rodent handling, restraint, and basic procedures.
• Familiarity with dosing techniques (IV, IP, SC, PO).
• Experience in a preclinical CRO, biotech, or pharmaceutical environment.
• Understanding of IACUC, AAALAC, and animal welfare regulations.

Physical Demands

N/A

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

ALAT certification (AALAS) preferred

Compensation

$55,000 to 75,000 per annum

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No Open Roles At This Time

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