Junior QC Analyst
This role is an excellent opportunity for a junior professional to join our QC Bioanalytical team and contribute to the success of our organization. The ideal candidate will have at least 1 year's experience working within the QC Bioanalytical/QC field within a Pharmaceutical GMP lab.
The key responsibilities of this role include:
* Reagent management, media preparation.
* GMP document review and management.
* Sample and data management and some analytical testing.
To be successful in this role, you will need to possess the following skills and qualifications:
* 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.
Additional responsibilities of this role include implementing continuous improvement projects, supporting a lean culture and Right First Time (RFT), and representing the QC unit by liaising with internal and external customers.
In terms of specific job duties, you can expect to:
* Work across diverse areas within the lab with a high degree of technical flexibility.
* 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.
* May participate in lab investigations.
* May provide technical guidance.
* May train others.
* May represent the department/organization on various teams.
* May interact with outside resources.
Your knowledge and skills should include:
* An understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.
* 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.
You will also be expected to possess the following competencies:
* 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.
* Folllows 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 agencies.