The Role:

QC Associate, Bioanalytical Sciences

The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.

Responsibilities:

• With a high degree of technical flexibility, work across diverse areas within the lab

• Plan and perform routine tasks with efficiency and accuracy.

• Review, evaluate, back-up/archive, and approve analytical data.

• Troubleshoot, solve problems and communicate with stakeholders.

• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning

• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

• Some / limited experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique

Requirements:

• Take initiative to identify and drive improvements

• Excellent verbal and written communication skills

. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)

. Presentation skills

. Escalate issues professionally and on a timely basis

• Decision Making skills

• Teamwork and Coaching others

• Negotiation and Influence skills

• Project Management and organizational skills, including ability to follow assignments through to completion

. Refers to technical standards, principles, theories and precedents as needed

. May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems

• Demonstrated leadership and communication skills

• Auditing documentation and operation process

• Demonstrated ability to interact with regulatory agencies

Relevant Experience:

• Bachelor’s degree in a science discipline.

• 1-2 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.