QC Reviewer
Altasciences
Summary
The QC Reviewer is responsible for performing quality control including daily in-process quality control on various projects. Ensures that all project's related documentation is filled out accurately and in a timely manner by the analysts and that all procedures are respected as per the company's SOPs.
Job description
About The Role
The QC Reviewer is responsible for performing quality control including daily in-process quality control on various projects. Ensures that all project's related documentation is filled out accurately and in a timely manner by the analysts and that all procedures are respected as per the company's SOPs.
What You'll Do Here
- Perform daily in-process quality control on multiple projects inter-team.
- Verify forms/paperwork, reports, and data tables generated by the analysts and scientist.
- In charge of the quality within the laboratory according to GLP, regulatory agencies requirements and internal sops.
- Support and mentor analysts during the generation of supplementary information forms as needed to ensure documentation accuracy and completeness.
- Ensure harmonization of techniques, procedures, and documentation between analysts in the laboratory.
- Conduct all work in compliance with the applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies.
- May respond to in-life QA report.
- May perform process verification QC: develops processes, executes and reports.
What You'll Need to Succeed
- College Degree and/or University degree in Biochemistry, Immunology or equivalent field.
- Experience in the medical field/and or pharmaceutical fields with typically 2 years of experience in data review and quality control field. Must understand general SOPs and have knowledge of GLP regulations.
- General advanced computer skills: proficiency working with MS-Office, Adobe Acrobat, Outlook.
- Ability to multi-task and maintain organization in fast paced, changing environment. Strong planning and organizational skills.
- Ability to work effectively and cooperatively in a team environment under significant time pressure. Demonstrated attention to detail and consistent ability to operate with accuracy and quality. Ability to successfully operate independently with minimal guidelines.
- Ability to work holidays, weekends and evening hours as needed.
Requirements
- College Degree and/or University degree in Biochemistry, Immunology or equivalent field.
- Typically 2 years of experience in data review and quality control field.
- Must understand general SOPs and have knowledge of GLP regulations.
- General advanced computer skills: proficiency working with MS-Office, Adobe Acrobat, Outlook.
- Ability to multi-task and maintain organization in fast paced, changing environment.
- Strong planning and organizational skills.
- Ability to work effectively and cooperatively in a team environment under significant time pressure.
- Demonstrated attention to detail and consistent ability to operate with accuracy and quality.
- Ability to successfully operate independently with minimal guidelines.
- Ability to work holidays, weekends and evening hours as needed.
Benefits
- Health/Dental/Vision Insurance
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Review
Company overview
Altasciences is a forward-thinking, mid-size contract research organization (CRO) and contract development manufacturing organization (CDMO) that provides integrated, full-service solutions for early phase drug development. Founded in 1992 and owned by Novo Holdings A/S, the company offers pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies. Their comprehensive services include preclinical safety testing, clinical pharmacology and proof of concept studies, bioanalysis, formulation development, manufacturing and analytical services, program management, medical writing, biostatistics, and data management. With over 1,800 employees across eight facilities in the U.S. and Canada, Altasciences has established itself as a trusted partner for drug development from lead candidate selection through clinical proof of concept and beyond. The company's integrated CRO/CDMO model enables seamless transitions between development phases, reducing complexities, mitigating risks, and accelerating timelines for clients ranging from startups to global pharmaceutical leaders.