Production Support Specialist

Bimeda•Cambridge, ON

11d•CA$65,000 - CA$75,000•Onsite

About The Position

Reporting to the Plant Manager, the primary role and tasks for the Production Support Specialist is to perform and coordinate all aspects of investigations of production/manufacturing related incidents and deviations to ensure compliance with pharmaceutical products manufacturing regulations and cGMP. A detailed oriented individual will conduct root cause investigations, close deviations on time, support assignment of proper corrective actions, and facilitate the implementation of corrective actions for manufacturing and operating processes. Using a hands-on approach, the specialist actively executes the deviation investigations, effective and efficient investigation writing, corrective and preventive actions development & implementation with production and supporting stakeholders. The Specialist will work closely with all in compliance with current FDA and Health Canada regulations, cGMP and GDP practices. Participation in Regulatory Agency inspections/activities required as needed.

Requirements

3-5 years of prior experience in an aseptic manufacturing environment required.
Training and knowledge of Good Manufacturing Practice regulations and standards.
Bachelor’s Degree in Life Sciences Microbiology or equivalent degree/diploma required.
Direct knowledge of cGMP regulations.
Able to develop, review and maintain metrics and quality audits.
Ability to prioritize and manage multiple tasks to demanding deadlines.
Able to interface directly with cross-functional teams.
High level of personal motivation.
Extremely detailed oriented and analytical thinker with strong problem-solving ability.
Excellent written and verbal communication skills.
Proven ability to build strong working relationships, internal and external to the organization.

Nice To Haves

Investigations experience in sterile manufacturing, filling & packaging environment.
Prior experience in Fishbone Investigation Procedure and A3 problem solving technique.

Responsibilities

Work directly with production and quality teams, on the manufacturing floor to collect and collate all required information, data and facts at the point of issue and deviation occurrence.
Meet and exceed performance and deliverable expectations of completing investigations and writing investigations on time as laid out by the plant manager.
Review batch documentation, testing results, training records, calibration records, policies, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents to support the deviation investigations and writing.
Lead the investigation closure of manufacturing compliance-related documents using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance on time.
Write deviations investigations using the right writing and compliance practices. Writing should be SMART – Specific & Situational, Measurable & Methodical, Actionable & Accurate, Realistic and Timely.
Engages and performs deviation investigations process by understanding the current state of process, sequence of flow, breaking down the problem into what, where, when, who, how: determines the point of cause, analyses and determines the real root causes by using various problem solving tools – Cause and Effect, 6M -Fishbone Analysis, 5 Whys, Pareto and Graphical Analysis, Process Capability Methods; and Right Countermeasure Development.
Use A3-8 Step problem solving methodologies to facilitate investigations.
Work with production and supportive stakeholders to determine possible countermeasures for CAPAs.
Deliver focused training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs, EHS regulations and any other CAPA improvements related training.
Identify and implement process improvements to drive success in the areas of quality, compliance, throughput flow, workplace safety, cost-effectiveness, and product lead time through CAPAs.
Keep current with new guidelines and Health Canada and FDA inspectional and scientific trends; and adjust CAPA procedures appropriately.
Work with management team to improve the quality of the process and the procedures.
Any other tasks and duties as assigned.