Quality Control Data Reviewer
1 week ago
Job Summary
The Quality Control (QC) Data Reviewer position is accountable to the QC Supervisor and is responsible for the review and approval of analytical data, electronic and paper based, ensuring compliance with data integrity requirements. The QC Data Reviewer is also responsible for the generation of protocols and reports, creation or revision of procedures/SOPs and for maintaining the schedule, to ensure timely and compliant release of commercial products.
Responsibilities
Data review of raw material, packaging components, operating supplies, in-process, validation, quality control and quality assurance protocol testing and drug product analytical testing. Occasional review of stability analytical testing data will be required. Review of laboratory notebooks, logbooks and other documents within the quality control area as required. Reviews calculations for correctness and ensures changes made are accurate and documented as per company Standard Operating Procedures (SOPs). This will involve performing standard calculations to confirm accuracy. Reviews, completes, and proofreads data forms, tables, and reports. Reviews electronic audit trails and electronic records, ensuring that data integrity is maintained as outlined in the companies' SOPs. Verifies that results comply with the company specification. Flags inconsistencies in review. Works directly with the person or team generating the analytical data under review to have documentation corrected and electronic data updated, as applicable. Immediately notifies their Supervisor, or designate, of any out of specification, out of trend or suspect result. Creates, revises, and manages technical and quality documents for the department such as protocols, reports, SOPs, logbooks, and batch records both in paper and in electronic formats. Provides project and routine support on the status of reviewed work to the supervisor, including assisting in scheduling and timing of review. Collects data and prepares reports for various projects and initiatives in the Quality Control laboratory. Prepares training packages, training documentation and schedules training sessions following SOPs on proper documentation and electronic data integrity. Provides assistance on a wide range of departmental projects. Follows GMP and regulatory requirements, and ensures quality standards are met. Models the Company Mission, Vision and Values Statements, policies, and current standard business practices. Performs other related duties and or special projects as assigned by the leader.Qualifications
Education
B.Sc. in Chemistry, Biochemistry or University degree in a related field.Experience
A minimum of 4-5 years of laboratory experience coupled with 1 to 2 years of peer review of lab data. Acute attention to detail. Well-developed time management skills and effective technical writing skills. Ability to work in a self-directed team environment. Familiarity with Empower and other laboratory software. Good understanding of Canadian and United States cGMP and cGLP guidelines and standard operating procedures. Proven track record in reviewing scientific documents to GMP standard Ability to use Microsoft Office applications, especially Excel, Word and Power Point.What we offer
Excellent compensation/benefits package. Bonus and reward programs Discounted gym memberships Programs supporting work life balance Employee recognition program Professional and personal development programs Social events and spirit days We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.
In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.
Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses or ) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.
Internal Job Posting Grade 8. The due date for internal applicants to apply for this role is May 21, 2024.
Contract type
Permanent
Position location
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