Senior Specialist, Quality Assurance at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmacy) or a related field
Minimum of 6 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry without degree
Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field, preferred
Familiar with GxP, FDA, ICH, and OSHA requirements
Familiar with Microsoft Office applications (Word, Excel, etc.)
Strong organizational skills and exceptional attention to detail
Able to work independently and as part of a team
Communication Proficiency, Problem Solving/Analysis, Results Driven, Technical Capacity, Thoroughness

Responsibilities

Assist in the maintenance and tracking of all Quality related documentation including, but not limited to: SOPs, Protocols, Deviations, Investigations, CAPAs, Change Controls, etc
Assist in maintaining all investigation and CAPA related documentation as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs, cGCPs and cGMPs
Assist in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the company’s electronic Quality System
Actively participate in the review and approval of batch record documentation (master and executed) to support quality release of drug product in a timely manner
Assist in change control management program and document archival
Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices
Perform quality review of documentation and processes
Assist with SOP revision and participates in inspections, as needed

Skills

Key technologies and capabilities for this role

SOPsCAPADeviationsInvestigationsChange ControlscGMPcGCPRoot Cause AnalysisBatch RecordsQuality Systems

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

This is a hybrid position requiring three days on site at the office in Burlington, MA, with minimal travel expected.

What are the key qualifications and skills required for this role?

A Bachelor’s degree in a scientific discipline like Biology, Chemistry, or Biochemistry is required, along with at least 6 years of experience in pharmaceutical manufacturing, quality assurance, or FDA regulated industry (without degree). Key skills include familiarity with GxP, FDA, ICH, and OSHA requirements, strong organizational skills, attention to detail, ability to work independently and in a team, plus communication proficiency, problem-solving, and technical capacity.

What benefits are offered for this position?

Benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability.

What is the salary range for this role?

Compensation may vary based on factors including geographic location, candidate experience, and skills, but no specific range is provided.

What experience makes a candidate stand out for this QA Specialist role?

Candidates with a Bachelor’s degree in Biological Science, Chemistry, Biomedical Engineering, or a relevant field, plus direct experience in pharmaceutical quality assurance involving SOPs, CAPAs, investigations, and GxP compliance in an FDA-regulated environment will be strongest.

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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