Jobs

Description

Role Overview

• We are seeking a Quality Assurance Specialist to support a global quality organization. This role focuses primarily on change control, quality documentation, and project coordination, rather than batch record review or heavy investigation ownership.
• The ideal candidate will be bilingual (English & Spanish), proactive, and capable of working independently while supporting cross-functional global teams.

Manager’s Update

• Support change control processes and related documentation updates
• Manage and maintain quality documentation (SOP updates, training records, document control)
• Assist with quality projects (administrative/project coordination support)
• Retrieve and analyze data using SAP (lot genealogy, traceability)
• Support investigations and change requests (documentation & coordination, not full ownership)
• Collaborate with global stakeholders; occasionally lead meetings or presentations
• Work closely with internal leads while handling tasks independently
• Quality experience in regulated environment
• Strong experience in Change Management / Change Control
• Experience with Quality Documentation (SOPs, training, updates)
• Bilingual: English & Spanish (Required)
• Ability to work independently with minimal supervision
• Strong communication & coordination skills
• Bachelor’s Degree in Science (Biology, Chemistry, Life Sciences) OR Engineering (any relevant discipline)

Preferred Skills (Nice-to-Have)

• Experience with SAP (lot genealogy, data lookup)
• Exposure to systems like OneVault, OneTrack, SolTrack
• Basic project management / coordination experience
• Experience supporting global teams

Purpose:

• The Quality Associate supports the Global Biologics Quality Function within Operations. Expectations that the Quality Associate III will maintain high quality levels on all aspects of their job, while achieving high levels of efficiency.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Responsible for various aspects of the product’s quality assurance related to their functional area.
• Ensures that product is consistently manufactured in conformance with Client’s Quality System requirements and all applicable regulatory requirements throughout the network, including third party manufacturers.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with management for Quality Initiatives, Projects, Product Transfers, etc.
• Incumbent is responsible for ensuring compliance with Client’s Quality Systems and cGMPs.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 4+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• Must also be familiar with Client Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication Skills, both oral and written.

What are the top 3-5 skills, experience or education required for this position:

• Change and investigation documentation
• Bilingual
• Bachelor’s Degree in Science or Eng
• +4 years of experience in Quality area position
• if possible, experience with project management

Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree or 3-5 years equivalent experience.

Experience Level = 3 to 5 Years