Main Purpose of the Position
As directed by the QC Supervisor, the Biochemist: Responsible for conducting quality analysis of bulk, in-process and finished goods under limited or no supervision and according to standard operating procedures. The Biochemist should demonstrate proficiency in all applicable QC techniques, operation of relevant equipment and software packages associated with testing, data analysis, interpretation and reporting. Able to performs troubleshooting, investigations, provide and follow corrective/preventive actions for failures and non-conformances. Deputize the QC Supervisor for the assigned responsibilities, when needed.
Primary Responsibilities and Duties
- Plant Start-up activities require the QC Biochemist to support the laboratory planning and product testing planning per schedule and assignments.
- Lead QC technical transfers activities, such as test methods implementation, execution of pilot and validation runs for applicable QC methods.
- Participate in the establishment and proper maintenance of the cell bank.
- Perform all assigned QC tests following analytical methods and procedures for products.
- Assures bulks and/or finished products conform to established specifications.
- Reviews data on all QC testing as assigned. Performs investigation for atypical or Out of Specification results and makes recommendations.
- Provide technical guidance to resolve issues and follow-up on actions.
- Support complaint investigations and report results.
- Perform material transactions on SAP system.
- Carries out the assigned direct supervisor responsibilities during his/her absence.
- Ensures that cleaning, maintenance and calibration of QC equipment take place according to schedule.
- Ensure the required docs/records are available.
- Support the set up the Vivarium for plant start-up.
- Participating in the preparation of the relevant documents, procedures to be implemented.
- Support the vivarium associates and activities.
- Assists in development and evaluation of new procedures and techniques and analyzes in detail existing methods to suggest improvements.
- Provide recommendations to continuously improve product/process quality.
- Leads and execute Continuous Improvement projects and communicates project status.
- Assists in training.
- Maintain working knowledge of current industry and international standards.
- Initiates changes to practices and procedures to support compliance requirements.
- Assures finished products conform to internal and government standards and satisfies ISO regulations.
- Address corrective actions whenever a hazard is identified.
Training & Compliance:
Requirements (Knowledge, Skills, and Abilities)
- Requires a Bachelor Degree in a related scientific discipline (such as Biology, Microbiology or Medical Technology) and a minimum of four years of experience in a pharmaceutical/ biotechnology environment and/or medical technology laboratory or equivalent combination of related education and experience.
- Working experience with Western Blot, ELISA, Flow Cytometry
- English language knowledge is preferred
- Chemical Engineer
- Environment, Agriculture
- Healthcare, Pharmaceutical Industry
- Healthcare Specialist
- Full time
- 3-5 years professional experience
Required language level:
- English - intermediary/communicative
How to apply/ contact information:
If this describes you and you are interested, please send your CV.