Document Reviewer

**Job Summary**:
To conduct, with minimum supervision, reviews of tests of raw materials and finished products in accordance with current compendial and in-house procedures to assess the compliance with domestic and foreign regulatory requirements, as well as Canadian Analytical Laboratories standards. Also to perform activities of the Quality Assurance department in strict accordance with all Standard Operating Procedures, GMP, company policies and procedures. The key objective of this role is to work in all quality assurance systems and ensure they meet all relevant regulatory requirements of the pharmaceutical industry.

**Key Responsibilities**:

- Review all test documentation for accuracy and completeness according to cGMP’s
- Responsible for timely and effective GMP review and release of analytical documentation in order to maintain a continuous pipeline flow of process of releasing the test results ensuring GMP and SOP’s are followed
- Adheres to internal/external guidelines, policies, procedures, specifications and regulatory requirements while reviewing and releasing analytical documentation
- Addresses deficiencies to maintain consistent resolutions to all document review
- Drives timely resolution of deviations related to analytical records, disposition of analytical data Reviews all batch documentation for accuracy and completeness according to cGMPs to ensure timely release
- Evaluate OOS result Conduct OOS investigations
- Review calibration data when required
- Perform all other duties as assigned
- Positively interacts with internal associates to quickly and effectively resolve issues
- Addresses deficiencies and ensures completion of all follow-up actions according to GMP standards and company objectives
- Review and maintain internal and external equipment calibration records
- Manage all aspects of quality documentation issuance and returns inclusive of all laboratory logbooks and notebooks
- Distribute SOPs and analytical procedures to laboratories and maintain QA documentation system.
- Maintain the process for the execution, investigation and documentation of all laboratory OOS occurrences
- Review stability protocols
- Maintain records for appropriate retention times
- Review standard receiving reports and approve reference standard labels
- Maintain overall CAPA program to include investigation, root cause analysis, corrective and preventative actions and documentation

**Minimum Requirements**:

- Degree in the Life Sciences preferably in chemistry or equivalent
- At least 3 years’ experience in the area of chemical test laboratory
- Considerable knowledge of basic chemical concepts
- Proven ability to work in a safe manner and maintaining a clean and organized work environment
- Competency in clearly and fluently expressing concepts and ideas in English, orally and in writing
- Ability to work as a member of a team and under minimum supervision

**Laboratory Operations During COVID-19**:
As an essential service provider, Canadian Analytical Laboratories is open to continue to support our community.

We continue to closely monitor the COVID-19 situation as well we are working to comply with advice being provided by both levels of the Canadian government.

Our parent company, Reena Group provides essential goods and services to the pharmaceutical, food, natural health products and medical cannabis industries, who are playing a pivotal role in responding to the crisis by ensuring the availability of products and supplies necessary to respond medically and economically both in Canada and the United States.

During this unprecedented time, our number one priority is the safety of our employees, customers and communities. To continue to serve our laboratory client community, we have proactively adopted modified working practices, staggered working hours and taken all the warranted precautions to mitigate the risk of COVID-19 transmission and to ensure a safe environment to ensure that we comply with the principles of social distancing.

**Job Types**: Full-time, Permanent

**Benefits**:

- Dental care
- Extended health care
- Vision care

Schedule:

- 8 hour shift

Supplemental pay types:

- Bonus pay

Ability to commute/relocate:

- Mississauga, ON: reliably commute or plan to relocate before starting work (preferred)

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Document Review in a Pharm Lab: 1 year (preferred)