Job Title: Production Support Specialist

Location: Cambridge, ON (In-Office) Position Type: Full-time regular Shift: Day Shift, Monday - Friday Vacancy Status: This role is currently vacant AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Role Summary

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.

Key Role Specific Requirements

Deviation Investigations & Writing 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.

Continuous Improvement

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.

Training

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.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing. ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this. THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled. PLANNING – is the process of thinking about and organizing the activities required to achieve a desired goal. CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose, and embraces change. Strives for continuous improvement.

Other Requirements

Essential: 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.

Desirable

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

Compensation & Benefits

Competitive salary. 13 paid holidays. Competitive vacation policy effective upon hire. 5 paid personal care days. Employee Assistance Program. Medical, dental, vision, STD & LTD benefits.

Expected Salary Range: $65,000 - $75,000 / Year, DOE

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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More Info at www.bimedacareers.com