Qc Document Reviewer Level 1 Micro/chemistry

4 weeks ago

Markham, Canada SGS Full time

Company Description

WE ARE SGS - THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 89,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD.

**Job Description**:
Performs review and approval of analytical data based on document review for Microbiology and Chemistry in a timely and effective manner according to methods, instructions, procedures, good laboratory documentation practices (GDP), good manufacturing practices (GMP) and standard operating procedures (SOPs) of SGS Life Science Services Analytical Laboratories and Departments.
- Principles and practices of test methods and regulatory programs related to Microbiological testing.
- Review the data to Comply with GLPs, cGMPs, and GDP (Good Documentation Practice).
- Good knowledge of USP, EP, BP, and JP methodology
- Understanding of various Microbiology instruments and data generated from them (Vitek 2, Autoclaves, incubators)
- Microbial Enumeration Testing
- Test for Specified Microorganisms
- Water testing
- Assures that reviewed QC records are compliant to methods, specifications and company’s applicable Standard Operating Procedures.
- The review is done according to QAM-210 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.
- Ensures test results are reported appropriately on either a C of A or a R of A depending on the validation/transfer status of the method.
- Assures review of data in a timely manner and approval of records prior due date.
- Assures method development records are reviewed as per SGS SOPs.
- 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.
- Informs analyst or his/her supervisor to initiate out -of-specification and/or issue OOS form in case of OOS, which was not noted by analyst.
- Audits all record books (logbooks) associated with testing reviewed / approved.
- Has and maintains documented, approved Qualified Trainer record for the aspects he/she trains others. Trains new Document Auditor for some test methods, review GDP process and SGS SOPs Requests deviation to be reported or issues a deviation report in case where method or SOP was not followed as written.
- Ensures that documentation review is complete in every respect and reviews that all results are entered into the electronic laboratory information system LIMS.
- Revises forms for execution of methods and procedures; issues CCR for method change and new worksheet generation.
- Attends training sessions and ensures that training binder is current. Has a
- training record for every SOP version executed, if applicable; If absent during training sessions, ensures training is performed and documented.
- Reviews and approves their preparations and labeling.
- Requests training if work assigned requires knowledge of SOP with no record of training or reads and asks questions about SOPs in training.
- Incumbents are responsible for their own training records according to training SOP.
- Audits calibration related documents and other QC documents.
- Inputs data for trending departmental KPIs.
- Identifies, participates in and sometimes leads operational improvement initiatives.
- Minor participation in regulatory, and client audits needed.
- Trains departmental staff on documentation and regulatory issues.
- Review of staff training records.

**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.
- Ability to critically evaluate and review almost all test records generated by SGS
- As per SOP PSL-311-06 all employees must maintain appropriate attitude, constant vigilance and attention to detail. Understanding of the lab quality control / quality assurance processes, GMP and GDP as it relates to pharmaceutical testing
- Comfortable with electronic systems (e.g., LIMS) and other lab equipment to be able to perform audit trail of testing records
- Well organized, autonomous and able to deliver good quality work efficiently
- Able / willing to learn new skills (review of new tests,

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