Biotech Document Reviewer
Biotech Document Reviewer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Assures that reviewed QC records are compliant to methods specifications and companys applicable Standard Operating Procedures.
- The review is done according to QAM210 Data Review SOP
- Identifies area for improvement of SGS SOPs analytical methods and forms.
- Follows deadlines specified on a lab sheet or as scheduled by their supervisor.
- Assures records of Validation/Method Transfer/Verification and reports are as per protocol and method provided by clients or written by SGS
- Assures that OOS and deviation are closed before forwarding the records to QA for release of C of A.
- Issues an audit form noting deficiencies to method and procedures returns the form to analyst for correction according to Data Review SOP; Ensures that all valid deficiencies are corrected; escalates all concerns to management.
- Ensures that documentation review is complete in every respect and reviews that all results are entered into the electronic laboratory information system LIMS.
- Audits calibration related documents and other QC documents
Qualifications :
- Education: Bachelor of Science degree (or equivalent combination of education and experience such as College with 10 years of pharmaceutical QC testing/records review experience) in Chemistry Biochemistry Biology Microbiology or related biological science or equivalent in job experience
- Experience: over 2 years experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical company.
- Previous experience with molecular biology and electrophoresis techniques (ie western blot/SDSPAGE)
- Comfortable with electronic systems (eg. LIMS) and other lab equipment to be able to perform audit trail of testing records
- Extended hours shift work or weekend work may be required from time to time.
- Ability to learn quickly in a challenging environment.
- Excellent language writing and communication skills required.
Additional Information :
SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression and Indigenous status or any other characteristics protected by law.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge skills and/or abilities required.
This job description should not be construed as an exhaustive statement of duties responsibilities or requirements but a general description of the job. Nothing contained herein restricts the companys rights to assign or reassign duties and responsibilities to this job at any time.
Accommodations are available on request for qualified candidates during each stage of the recruitment process.
Please note that candidates applying for Canadian job openings should be authorized to work in Canada.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
