Specialist, Compliance

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

Job Summary
The focus of this role is to support the manufacturing team with achieving and maintaining a high level of cGMP compliance within the Company to meet client, regulatory agency, and RESILIENCE expectations.

Major Responsibilities

• Review of executed Batch Production Records (BPR) and ensure timely turnaround to Quality department and client.
• Assist with investigations (Deviations, Out-of-Specification, and Environmental Monitoring Excursions) and ensure timely closure.
• GMP document control which includes but not limited to creation/revision/closure of CCs, DCCs, CAPAs, SOPs, logbooks, MCCPs.
• Review Effectiveness Checks as result of CAPA execution and ensure timely closure.
• Initiate Change Controls related to documents and equipment for manufacturing, ensure execution and timely closure.
• Assist with completing CAPA actions and ensure timely closure of CAPA records for the Manufacturing Department.
• Assist with addressing audit observations (internal, client, regulatory) and ensure timely closure.
• Conduct regular inspections during GMP batches to assess GMP and GDP compliance, and report any issues identified to management.
• Responsible for compliance logbook reviews on the floor.
• Review and assess alarms for manufacturing areas as per procedure.
• Provide proactive leadership in quality & compliance goals forward within the department to assist in maintaining departmental KPIs to monitor trends for process improvement.
• Ensure timelines for batch start are achieved by timely request of documents required for the batch.
• Work closely with department staff to assist them in implementing effective risk based GMP processes, procedures and documentation.
• Perform all other job-related duties as assigned.

This position is a fixed-term 12-month contract position.
Preferred Qualifications / Experience

• University degree or equivalent in science
• 1-3 years of pharmaceutical experience in manufacturing, quality, or compliance
• Knowledge of GMP guidelines, Health Canada, FDA, EMEA
• Previous experience in a Quality function

Behavioural
Demonstrate ability to apply the following behavioural competencies on the job:

G
*oal Orientation:*
Energetically focusing efforts on meeting a goal, mission or objective

Leadership:
Achieving extraordinary business results through people

Problem
Solving:
Anticipating, analyzing, diagnosing and resolving problems

Interpersonal
Skills:
Effectively communicating, building rapport, and relating well to all personality types

Decision
Making
:
Utilizing effective process to make decisions

This job
profil
e
provides an overview of the minimum
requirem
ents o
f
the job
and does
not
in
c
lud
e
all
o
f th
e
duties
inhere
nt
,
included
o
r
associated
with the job or with the performance of
th
e job
.
The Company reserves
th
e right
t
o make changes
to
the job
profile
as
it sees fit to meet
the
needs
of the organization
.
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 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 $ $33.00 per hour. 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.