Document Associate Ii

2 weeks ago

Toronto, Canada Centre for Commercialization of Regenerative Medicine Full time

**About CCRM**:
**Role Summary**:
As Document Associate II at CCRM, you will join the team at the Centre For Cell and Vector Production (CCVP), a Good Manufacturing Practices (GMP)-compliant facility manufacturing regulated products to enable clinical translation of cell and gene therapies. You will help to develop CCRM’s documentation teams to deliver on client demands, including fee-for-service work, contract manufacturing, access to services, technology transfer, training, and technical and process development services. You will work within the team to develop/review/revise Operations department documentation, and execute day-to-day duties as assigned by your manager. You will assist in bringing new and innovative products to market to enable life-saving advances in cell and gene therapy, and regenerative medicine.

**. Responsibilities**:

- Review Master Batch Records (MBRs), forms and/or logs to ensure GMP compliance, Good Documentation Practices (GDP) and established CCRM procedures.
- Create, revise and review all regular documents (e.g., Standard Operating Procedures (SOPs), incident/deviation reports, change controls, corrective and preventive actions (CAPAs), environmental monitoring (EM) excursions) in a superiour, time efficient and proactive manner.
- Assure that reviewed batch records are compliant with approved methods, specifications and CCRM’s applicable SOPs.
- Ensure the Protocols and SOPs have been followed by the Operations Associates and Leads.
- Assist with preparing and issuing batch records and in-process labels for batch manufacturing.
- Actively participate in investigations and audit meetings with both internal and external stakeholders.
- Ensure that all deficiencies are corrected and escalate all concerns to management.
- Verify the integrity and traceability of all data generated and reported.
- Follow up with Operations Associates and Leads to ensure that all necessary corrections are corrected in accordance with GMP standards and CCRM’s SOPs.
- Assist with maintaining and continuously improving quality systems.
- Notify department leads/coordinator/supervisor/manager regarding omissions, incomplete documents or other irregularities.
- Demonstrate the CCRM values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.
- Assist Sr. Document Associate and Document Coordinator, as needed.

**Requirements**:

- Bachelor of Science in chemistry, biochemistry, biology, microbiology or another related biological science, or have equivalent job experience in a biopharmaceutical company.
- Familiarity with the applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as cGMP, ISO or medical device development.
- Minimum two years of Documents Associate/QA experience in a biopharmaceutical GMP environment. Familiar with current ALCOA principles.
- Ability to prioritize and manage conflicting demands.
- Detail-oriented self-starter with excellent problem-solving and analytical skills, and the ability to multitask and succeed in a team environment.
- Excellent written and oral English communication skills
- Strong record-keeping and documentation skills.
- Excellent proficiency with basic computer software (e.g. Microsoft Office, SharePoint, Excel, PowerPoint, Word).

**Desired Characteristics**:

- Understanding of United States Food & Drug Administration (FDA) regulations, International Conference of Harmonization (ICH) guidance and Quality Assurance principles.
- Experience with electronic quality management systems.
- Strong knowledge and understanding of contract development manufacturing organization (CDMO) businesses.
- Ability to learn quickly in a challenging environment.
- Ability to prioritize effectively to meet deadlines.

CCRM is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

CCRM is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.

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