Senior Specialist II, QA Operations (Sterility Assurance)

at  Resilience

A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit
www.resilience.com
Position Summary:
The position is accountable for championing sterility assurance principals at the site and serving as the microbial control technical leader in the areas of aseptic processing, contamination control and viral safety. This role supports the site compliance to microbial/viral control standards/procedures on environmental monitoring, critical utilities, , cleanroom management, aseptic processing controls, disinfectant efficacy studies and microbial risk assessments. In addition, this role is also responsible for addressing QA activities as assigned by the Senior Manager, QA Operations relating to clinical and commercial manufacturing. Responsible for ensuring GMP compliance in line with US FDA, Health Canada, EU requirements, and other regulatory bodies and standards.
This is a site based position in Mississauga, ON.

Position Responsibilities:

• Responsible for maintaining site Contamination Control Strategy (CCS) and risk assessments related to Annex 1 and CCS compliance.
• Lead site microbial and cross contamination LOPA and HACCP risk assessments.
• Support QC microbiology deviations, LIR, OOS, Change Control and CAPA records by providing sterility assurance guidance.
• Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements.
• Support Aseptic Filling/ Manufacturing surveillance and Quality Oversight of GMP activities
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls
• Perform checks or audits on production activities to ensure all work is performed in full compliance with GMP, SOP and related regulatory requirements.
• Interface with client, as required.
• Collaborate and effectively communicate with internal customers, as necessary, to provide required documentation and/or resolve documentation or compliance issues.
• Assist with the GMP and procedural training program for department’s new hires and current employees as required.
• Address gaps and perform revisions to departmental SOPs, forms, and processes to streamline systems and ensure compliance to GxP and related company and regulatory requirements.
• Provide proactive leadership in moving quality & compliance goals forward throughout the organization and achieving positive and value-added results.
• Perform all other job-related duties as assigned by the Senior Manager, Quality Operations from time to time.

Minimum Qualifications:

• Extensive experience in a sterile manufacturing environment
• Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, endotoxin testing, and microbiological control strategy.
• Demonstrate knowledge of cGMP/ICH/FDA/EU/Health Canada compliance regulations
• Knowledge and familiarity with Annex 1
• Excellent problem-solving, risk management and communication skills.
• Demonstrated good judgement and analytical skills
• Strong ability to network with senior leadership personnel
• Advanced competency in specific computer systems and applications

Preferred Qualifications:

• Training in microbiology and sterility assurance is an asset.
• University Bachelor’s degree or degree recognized as equivalent by Canadian University/ Canadian accreditation body in Microbiology, Chemistry, or related field.

This position may also include the following conditions:

• Pre-employment medical and medical re-examination;
• This position requires vaccination for Hepatitis A and B
• Job may require extended shifts

The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $90,000.00 - $131,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

• Responsible for maintaining site Contamination Control Strategy (CCS) and risk assessments related to Annex 1 and CCS compliance.
• Lead site microbial and cross contamination LOPA and HACCP risk assessments.
• Support QC microbiology deviations, LIR, OOS, Change Control and CAPA records by providing sterility assurance guidance.
• Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements.
• Support Aseptic Filling/ Manufacturing surveillance and Quality Oversight of GMP activities
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls
• Perform checks or audits on production activities to ensure all work is performed in full compliance with GMP, SOP and related regulatory requirements.
• Interface with client, as required.
• Collaborate and effectively communicate with internal customers, as necessary, to provide required documentation and/or resolve documentation or compliance issues.
• Assist with the GMP and procedural training program for department’s new hires and current employees as required.
• Address gaps and perform revisions to departmental SOPs, forms, and processes to streamline systems and ensure compliance to GxP and related company and regulatory requirements.
• Provide proactive leadership in moving quality & compliance goals forward throughout the organization and achieving positive and value-added results.
• Perform all other job-related duties as assigned by the Senior Manager, Quality Operations from time to time