Quality Assurance Specialist

General Functions

This position is a key quality and compliance advisor for GMP operations. Notably, the individual

will oversee and directly contribute to quality activities related to commissioning of a Phase 1 GMP

compliant production facility, including creation and execution of quality aspects of a master

validation plan and related quality systems. In addition, the incumbent will provide basic plant QA

services such as reviewing executed batch production records, document change requests,

deviations, change control and internal audits, assisting in external audits, as well as, advanced

troubleshooting with internal and external customers to ensure compliance with approved

procedures and GxP expectations. The position requires integration of quality operations with

various internal and external service organizations providing cGMP services and / or materials.

This individual works internally and externally with development, manufacturing, laboratory,

quality and compliance staff. S / he may assist in interactions with FDA and other regulatory

inspectors during inspections of Quality operations.

ESSENTIAL POSITION FUNCTIONS

I. Author, review, and revise institute-level Quality Systems procedures and policies

II. Review and approve manufacturing and contractor documents : SOPs, component

specifications, Forms, production records, and logbooks, IOQ protocols

III. Perform line clearance of GMP manufacturing facility for production readiness

IV. Facilitate GxP training activities, including establishing and maintaining employee training

files

V. Intake, quarantine and release of raw materials and critical production materials

VI. Change Control activities including document change control review, approval, processing

and document retention.

VII. Provide Quality guidance and support for the development and implementation of

Quality Assurance policies and procedures and provide direct QA support to all GMP

programs and activities.

VIII. Conduct audits and manage contracted audits. Prepare written reports of audit

observations, including an assessment of compliance. Assess adequacy of CMO’s action plan

and conduct follow up activities as needed to monitor corrective actions.

IX. Review release test and stability data ensuring data accuracy, conformance to test

procedures, specifications, and documentation standards. Assure compliance and integrity of

CofA deliverables.

X. Assist in the development of additional quality systems necessary to assure compliance with

all applicable regulatory requirements, industry and Institute standards.

KNOWLEDGE, SKILLS AND ABILITIES

• Established commitment to the mission of the Human Challenge Center
• Knowledgeable and skilled at interpreting and applying regulatory requirements (cGMP and FDA drug / biologics) as appropriate.
• Must be accurate and detail oriented, possess strong organizational and time management skills and the ability to prioritize competing priorities in a complex and fast paced environment
• Superior written and verbal communication skills; and the ability to synthesize information from diverse sources
• Ability to make recommendations to effectively resolve problems or issues, by using judgment that is consistent with internal standards, practices, policies, procedures, regulation and government law
• Outstanding judgment, troubleshooting and decision-making ability and experience

EDUCATION AND WORK EXPERIENCE

• Bachelors degree in a scientific discipline or equivalent
• 5 years of related experience in a cGMP / FDA regulated industry with significant Quality Assurance experience.
3 days ago