Onsite Quality Assurance Senior Associate, GMP/PQA

Collabera; Holly Springs (NC); Sur place; USD 41 000 - 48 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Life insurance

Long-term disability insurance

Paid parking

Résumé du poste

Collabera in Holly Springs, NC seeks a Quality Assurance Senior Associate to join onsite for a 12-month assignment. The role requires manufacturing and PQA background with on-the-floor quality oversight in a bulk drug substance environment.

The position involves shift-based, fully onsite work with potential nights and weekends. You will support regulatory compliance, CAPAs, deviations, and audits while collaborating with manufacturing and quality teams to ensure GMP/GDP compliance.

Qualifications

• Must have manufacturing and PQA background.
• On-the-floor QA oversight and support for bulk drug substance manufacturing.
• Ability to coach, guide and direct manufacturing events, deviations and quality systems.

Responsabilités

• Provide ongoing quality oversight to ensure products are manufactured, tested, stored and distributed per cGMP and GDP.
• Ensure facilities, equipment, materials and processes comply with GMP and related regulations.
• Drive closure and approval of cGMP documents, deviations, investigations and CAPAs.
• Ensure production and testing records are complete and compliant.
• Oversee on-the-floor analytical testing and guidance.
• Assess changes that could impact product quality per procedures.
• Investigate and document deviations per procedures.
• Alert senior management to quality, compliance, supply and safety risks.
• Provide project management support and lead system implementation efforts.
• Identify and implement continuous improvement opportunities.
• Support and represent PQA during audits and inspections.

Connaissances

Manufacturing experience

PQA background

Description du poste

Collabera in Holly Springs, NC seeks a Quality Assurance Senior Associate to join onsite for a 12-month assignment. The role requires manufacturing and PQA background with on-the-floor quality oversight in a bulk drug substance environment.

The position involves shift-based, fully onsite work with potential nights and weekends. You will support regulatory compliance, CAPAs, deviations, and audits while collaborating with manufacturing and quality teams to ensure GMP/GDP compliance.