Biotech Document Reviewer (1 Year Contract)

SGS; Mississauga; On-site; CAD 37,000 - 44,000; Full time

Job summary

SGS is seeking a QC Records Reviewer in Mississauga to ensure reviewed data complies with methods and SOPs, following the QAM-210 Data Review SOP. The role involves identifying SOP improvements, meeting deadlines, and ensuring all data is accurately recorded in the LIMS system.

We require a Bachelor of Science or equivalent with 2+ years in a pharma-regulated lab, strong written and verbal communication, and the ability to work under pressure with extended hours if needed.

Qualifications

• Over 2 years’ experience in a pharmaceutical regulated laboratory.
• Comfortable using electronic systems (LIMS) and lab equipment.
• Excellent written and verbal communication skills.
• Ability to learn quickly in a challenging environment.

Responsibilities

• Ensure reviewed QC records comply with methods and SOPs.
• Review according to QAM-210 Data Review SOP.
• Identify areas for improvement of SGS SOPs and methods.
• Meet deadlines on lab sheet or supervisor schedules.
• Ensure records of Validation/Method Transfer/Verification meet client specs.
• Close OOS and deviations before QA release of C of A.
• Audit forms for deficiencies and escalate concerns.
• Ensure documentation review is complete and results entered into LIMS.
• Audit calibration documents and other QC documents.
• Input data for trending departmental KPIs.

Skills

Communication skills

Written communication

Under pressure

Adaptability

Education

Bachelor of Science

College with 10 years pharma QC experience

Tools

LIMS

Job description

• Contract
• Compensation: CAD 27 - CAD 32 - hourly

Company Description

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

• 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 improvment 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 reviewes that all results are entered into the electronic laboratory information system LIMS.
• Audits calibration related documents and other QC documents;
• Inputs data for trending departmental KPIs;

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.
• Comfortable with electronic systems (eg. LIMS) and other lab equipment to be able to perform audit trail of testing records
• Works well under pressure.
• Extended hours or weekend work may be required from time to time.
• Shift work may be required
• 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 company's 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.