indeed
Production Support Specialist
Bimeda
Cambridge, CAN
Full Time
Mid
Onsite
CAD 75,000/year
4 days ago
Root Cause AnalysiscGMPDeviation InvestigationCorrective and Preventive Actions (CAPA)Problem SolvingAttention to Detail
Free
Job Fit Check
Base Career helps you apply smarter for this job.
?%
Ready to ScanKey skills for this role
Root Cause AnalysiscGMPDeviation Investigation
About the Role
Bimeda seeks a Production Support Specialist to investigate manufacturing deviations and ensure cGMP compliance. You will conduct root cause investigations, write deviation reports, and implement corrective actions in a pharmaceutical environment.
Key Skills for This Role
Root Cause AnalysiscGMPDeviation InvestigationCorrective and Preventive Actions (CAPA)Problem SolvingAttention to Detail
Responsibilities
- Perform and coordinate investigations of production/manufacturing related incidents and deviations
- Conduct root cause investigations and close deviations on time
- Support assignment and implementation of proper corrective actions
- Work directly with production and quality teams on the manufacturing floor to collect information
- Review batch documentation, testing results, training records, and other technical documents
- Write deviation investigations using SMART writing practices
- Engage in continuous improvement using problem solving tools like Fishbone and 5 Whys
- Deliver focused training programs on cGMP and EHS regulations
Requirements
- 3 5 years prior experience in an aseptic manufacturing environment
- Bachelor's Degree in Life Sciences Microbiology or equivalent
- Training and knowledge of Good Manufacturing Practice regulations and standards
- Direct knowledge of cGMP regulations
- Ability to develop, review and maintain metrics and quality audits
- Excellent written and verbal communication skills
- Extremely detailed oriented and analytical thinker with strong problem solving ability
- Investigations experience in sterile manufacturing, filling & packaging environment (desirable)
- Prior experience in Fishbone Investigation Procedure and A3 problem solving technique (desirable)
Full Job Posting
Role Summary
- Reporting to the Plant Manager, the Production Support Specialist performs and coordinates investigations of production/manufacturing related incidents and deviations.
- Ensures compliance with pharmaceutical products manufacturing regulations and cGMP.
- Conducts root cause investigations, closes deviations on time, and facilitates implementation of corrective actions.
Key Role Specific Requirements
- Work directly with production and quality teams on the manufacturing floor to collect information.
- Meet performance and deliverable expectations for completing investigations on time.
- Review batch documentation, testing results, training records, calibration records, policies, SOPs, etc.
- Lead investigation closure using quality and statistical tools.
- Write deviations investigations using SMART writing practices.
- Engage in continuous improvement using problem solving tools (Cause and Effect, 6M, 5 Whys, etc.).
- Use A3 8 Step problem solving methodologies to facilitate investigations.
- Deliver focused training programs on cGMP and EHS regulations.
- Identify and implement process improvements through CAPAs.
- Keep current with Health Canada and FDA guidelines.
Competencies Required
- Effective communication: ability to convey information clearly and listen.
- Analytical thinking/problem solving: logical, systematic approach to problems.
- Thoroughness/detail oriented: ensuring complete and accurate work.
- Planning: organizing activities to achieve desired goals.
- Change agility/adaptability: supporting innovation and organizational change.
Other Requirements
- Essential: 3 5 years in aseptic manufacturing environment.
- Essential: Bachelor's Degree in Life Sciences Microbiology or equivalent.
- Essential: Training and knowledge of GMP regulations.
- Essential: Direct knowledge of cGMP regulations.
- Essential: Ability to develop, review and maintain metrics and quality audits.
- Essential: Excellent written and verbal communication skills.
- Desirable: Investigations experience in sterile manufacturing, filling & packaging.
- Desirable: Prior experience in Fishbone Investigation Procedure and A3 problem solving.
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: CAD 65,000 CAD 75,000 / Year, DOE.
About Bimeda
- Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products.
- Has over half a century's experience in providing science driven solutions.
- Operates nine manufacturing facilities across seven countries.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career