Purpose

The Quality Associate Specialist ensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements

This is a fully onsite shift role

Shift will be 4 days on, 4 days off with 12 Hour Shifts (7am – 7pm)

Responsibilities

Provide direct Quality support to production and support areas.
Provides presence on the shop floor to support compliance and data integrity.
Review and approve GMP documentation/data for accuracy and completeness.
Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents.
Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs.
Provides support to internal audits and regulatory inspections.
Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
General competencies:
Motivation to be an inspiring member of a high performing team.
Desire to continuously learn, improve and develop.
Leadership skills coupled with good oral and written communication skills.
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.
Technical writing skills.
-Lean Six-sigma and problem solving tools.

Qualifications

Bachelor degree, in a scientific or engineering field.
3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.