Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Responsibilities:

Research and address issues using problem-solving methodology, detailing in accordance with ALCOA principles and tracking metrics related to quality and compliance activities.

Lead quality and compliance processes, ensuring their successful execution and completion.

Lead quality audits team in support of GMP regulatory and client audits. Point of contact for regulatory audit support and audit observation responses.

Independently perform internal audits in support of the site goals.

Lead and/or participate in process improvement initiatives.

Collaborate with representatives from other departments to maintain quality and timelines for compliance activities, such as client audits and procedural documents.

Develop complex support materials, presentations, and tools to support the department's remit and strategies.

Provide training and mentorship to junior team members.

Job Requirements:

To excel in this role, you will need:

A bachelor's degree or equivalent experience, along with relevant formal academic/vocational qualifications.

Previous experience (comparable to 8+ years) that provides the knowledge, skills, and abilities to perform the job.

Effective oral and written communication skills in English.

Strong organizational and time-management skills.

Knowledge of the hosting GMP regulatory and client audits.

Detailed understanding of 21CFR211.

Highly developed problem-solving skills, including root cause analysis and corrective/preventive action.

The ability to work both independently and collaboratively in a team environment.

Strong leadership skills and attention to detail.

Proficiency in digital tools and software.

Working Conditions and Environment:

This position is an on-site role that requires the ability to walk through the facility and wear appropriate protective equipment.

Physical Requirements:

To perform this role, you should be able to:

Work in an upright and/or stationary position for 6-8 hours per day.

Make fast, simple, repeated movements of the fingers, hands, and wrists.

Move around frequently and occasionally crouch, stoop, bend, and twist.

Lift and carry objects, including luggage and a laptop computer, with a maximum weight of 15-20 lbs.

Access and use various computer software.

Communicate effectively and interact with diverse groups.

Work independently with little mentorship, requiring driven concentration and the ability to perform under stress.