QC Associate, Bioanalytical Sciences
Under minimal supervision, responsible for one or more of the following activities in QC including: Reagent management, media preparation, GMP document review and management, sample and data management and some analytical testing.
• Contributes to team by ensuring the quality of the tasks/services provided by self.
• Contributes to the completion of milestones associated with specific projects or activities within team
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.
Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.
Specific Job Duties:
• 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.
• Approve lab results
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on various teams
• May interact with outside resources.
• 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.
• 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
• 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
• Demonstrated ability to work independently and deliver right first time results
. Works under minimal direction
. Work is guided by objectives of the department or assignment
. Follows procedures
. 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 agenciesAPPLY NOW