What are the responsibilities and job description for the QC Specialist I position at Resolian?
Job Description
Resolian is a Contract Research Organization (CRO) specializing in Drug Metabolism and Pharmacokinetic (DMPK) and bioanalytical services for both small and large molecules.
At Resolian, we work to bring together and develop exceptional employees and colleagues who share our passion for generating significant contributions to the world. We take pride in our work and our employees. Resolian strives to help you and your family by offering a comprehensive benefits package.
Our total rewards are designed to recognize outstanding performance and meet the diversified needs of all our colleagues - at every stage of their professional and personal lives.
We continually strive to maintain the highest standards of professional ethics, scientific excellence, and regulatory compliance. We work to build trusted partnerships with each of our employees.
Please consider joining our experienced & knowledgeable staff. Resolian is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
Job responsibilities
- Learn and review documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11
- Verify lab tasks are performed in accordance with Good Documentation Practices (GDP)
- Review laboratory documents and notebooks (e.g., plans, experiment / sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations
- Learn to identify non-compliance and deviations
- Review sample analysis documents for compliance to validated / qualified methods
- Verify run pass / fail
- Follow applicable SOPs and procedural documents
- Review data result files, validation data files, and reports
- Learn to prepare and submit study data to archives
- Escalate data integrity and non-compliance issues to Management
- Enforce lab safety SOPs and requirements
- Review system audit trails
- Other tasks as assigned
Education, Skills & Qualifications
About Us
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.
