Quality Assurance Specialist III, PPQ/Commercial QA Projects

Avecia Pharma; Milford (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Assurance Specialist III to interface with clients and ensure compliance during manufacturing programs. This role involves overseeing quality assurance for commercialized products, requiring strong knowledge of cGMP regulations and excellent communication skills. The ideal candidate will have a background in science with several years of experience in GMP production or quality assurance, handling audits and client relations effectively.

Qualifications

• 3-5 years experience in GMP Production or Quality Assurance.
• Ability to provide expert advice on cGMP.
• Strong knowledge of quality systems and regulatory compliance.

Responsibilities

• Act as QA project team representative for client manufacturing campaigns.
• Prepare responses to customer QA agenda topics and lead discussions.
• Support audit hosts during Regulatory or Client audits.

Skills

cGMP regulations

Documentation

Change control

CAPA

Validation

Calibration

Failure investigations

Attention to detail

Education

BS/BA in Science

Job description

Press Tab to Move to Skip to Content Link

Select how often (in days) to receive an alert: Create Alert

Quality Assurance Specialist III, PPQ/Commercial QA Projects

Regular Full Time

About this opportunity :

In this role, you will be responsible for interfacing with and providing quality input to client’s manufacturing programs that are in late stages of development and/or commercialized. This includes interfacing with clients that are nearing process performance qualification (PPQ), PAI, and commercial readiness, and that are approved to manufacture in global regions.

Key Responsibilities:

• Act as QA project team representative along with department management on client manufacturing campaigns and at client meetings (e.g., onsite and teleconferences) as directed by QA department management.
• Prepare responses to customer-supplied QA agenda topics and lead discussions during client meetings, ensuring that any outstanding questions related to the agenda are addressed with QA project team department management.
• Provide a strong link/communication between the QA function/activities and all other departments at the Milford site.
• Support Customer QA SME along with department management in supporting Avecia’s Audit hosts during Regulatory or Client audits.
• Support the review and negotiation of client-specific quality agreements with sponsors and liaise with QA Regulatory Compliance to ensure that Avecia complies with stated GMP regulatory commitments.
• Ensure client-specific Corrective and Preventative Actions are implemented promptly and provide updates to clients as needed.
• Responsible for reviewing quality records.
• Support the review of Quality Assurance procedures that strengthen compliance with cGMPs related to QA project team responsibilities.
• Support the review and approval of client-specific deviations and gather/issue quality metric reports to executive management.
• Assist in customer complaint investigations as needed and follow up with customers until resolution is achieved.
• Support or perform disposition of advanced oligonucleotide products for pharmaceutical use, including intermediates, APIs, and adjuvants/constituent materials, according to specifications and procedures, including SAP transactions.

Required Skills/Abilities:

• BS/BA in science or equivalent work experience with 3-5 years’ experience in GMP Production or Quality Assurance.
• Ability to provide expert advice and sound decision-making on all aspects of cGMP.
• Strong knowledge of cGMP regulations and technical understanding of related issues, gained through experience in Quality Systems, education, and training in areas such as audits, documentation, change control, CAPA, validation, calibration, review of quality records, metrics, failure investigations, and manufacturing/laboratory controls.
• Ability to stay current with changing regulatory and cGMP requirements.
• Strong attention to detail and self-checking skills.