Contract - Quality Assurance Specialist at Vedanta Biosciences

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, MicrobiomeIndustries

Requirements

BS in Life Sciences with minimum 3 years in a pharmaceutical biotechnology environment
2-3+ years in a Quality Assurance role
Proficiency in application of FDA 21CFR 211 and Part 11, ICH Guidelines, EU GMP regulations to supplier quality requirements
Demonstrated ability to meet timelines and achieve results in a team environment
Basic knowledge of drug development process, knowledge CGMP/GDP agency regulations (e.g., FDA, EMA, Health Canada, ICH), and ability to apply standards appropriately to situations
Past participation in regulatory inspections or audits is a plus
Excellent verbal and written skills, allowing for an open and effective dialogue between departments and clear communication to senior management on status and program needs
Ability to work independently and think strategically to improve current processes
Personal Competencies: self-awareness, integrity, problem analysis, communication, risk management
Interpersonal skills: team and consensus building, effective meeting management
Ability to work onsite in Cambridge, Monday through Friday

Responsibilities

Ensure Vedanta facilities, utilities, manufacturing, and testing procedures and processes are compliant with GMP and phase-appropriate to support production and distribution
Support QA Operations in manufacturing activities including but not limited to on floor support, executed document review, disposition and release (internal and external CMO), walkthroughs, etc
Support QA Document/Training in document control activities including document upload to QMS system and archiving of records for both document and training
Own the revision of records and SOPs to align with GMP requirements as assigned
Collaborate with organization on the training of, and guidance/support of QMS system records such as Deviations, CAPAs, and Change Controls. Additionally own QMS System records as required
Lead, support, and/or implement improvement initiatives for QA and other organizations
Continue to improve or develop Quality Assurance department processes/guidance for internal interactions or between Vedanta and external stakeholders. Maintain documentation in accessible format, ensure new documents are created and stakeholders notified/trained as assigned
Provide guidance and mentoring on best compliance and industry practices within and across departments. Provide advice to others upon request
Support internal and external audits

Skills

Key technologies and capabilities for this role

GMPQA OperationsDocument ControlQMSSOP RevisionDeviationsCAPAsChange ControlsAuditsCGMP Manufacturing

Questions & Answers

Common questions about this position

What is the location for this Quality Assurance Specialist role?

The position is located in Cambridge, MA.

What are the education and experience requirements for this position?

A BS in Life Sciences with a minimum of 3 years in a pharmaceutical biotechnology environment and 2-3+ years in a Quality Assurance role are required.

What regulatory knowledge is needed for this QA Specialist role?

Proficiency in FDA 21CFR 211 and Part 11, ICH Guidelines, and EU GMP regulations applied to supplier quality requirements is required.

What compensation or salary information is provided for this contract position?

This information is not specified in the job description.

What soft skills or abilities are emphasized for strong candidates?

Demonstrated ability to meet timelines and achieve results in a team environment, along with basic knowledge of the drug development process, are key.

Vedanta Biosciences

Develops microbiome-based therapies using bacteria

About Vedanta Biosciences

Vedanta Biosciences focuses on developing microbiome therapies using groups of beneficial bacteria known as bacterial consortia. These consortia can colonize the human intestine and have the potential to treat various diseases. The company utilizes a proprietary discovery platform to identify and assemble these bacteria into effective therapeutic teams. Unlike many competitors, Vedanta has achieved commercial-scale production of its drug candidates while adhering to strict FDA regulations for safety and quality. The goal of Vedanta Biosciences is to transform disease treatment by providing new options for patients through its innovative approach to drug discovery.

Cambridge, MassachusettsHeadquarters

2010Year Founded

$364.5MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Risks

Competition from Seres Therapeutics with FDA-approved C. difficile treatment.

High production costs may impact profitability and market reach.

Regulatory challenges due to unclear FDA guidelines for microbiome therapies.

Differentiation

Vedanta uses defined bacterial consortia for consistent therapeutic outcomes.

First to achieve commercial-scale CGMP production of bacterial consortia drugs.

Proprietary platform identifies and assembles optimal bacterial consortia for therapies.

Upsides

Fast Track designation for VE303 accelerates regulatory approval process.

Phase 3 RESTORATiVE303 study positions Vedanta as a market leader for rCDI.

Recent $106.5M funding round strengthens financial position and growth potential.

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