JOB SUMMARY

Reporting to the QC Supervisor, the QC Analyst I is responsible for the analysis of raw materials, in-process, and finished product samples using various instrumental and analytical techniques while assuring compliance to cGMP, SOPs and Bimeda quality standards and requirements.

SHIFT AVAILABILITY:

1st Shift: Monday - Friday, 7:00am-3:30pm.

Role Specific Requirements:

• Conducts analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases and water. ie pH, Conductivity, TOC, Viscosity, Potency tests.
• Samples and performs identity testing on raw materials according to the schedule or as requested, utilizing approved sampling techniques for QC and Microbiology.
• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
• Prepares samples for analysis according to company SOPs & GLP methods.
• Performs specific analytical tests utilizing HPLC, GC, UV, IR, FTIR and other instruments.
• Analyzes data, keeps the supervisor informed of discrepancies, deviations, out of specifications (OOS) and unusual trends as they occur.
• Inform QC Supervisor to ensure that all reagents and supplies are replenished in a timely manner.
• Ensures work areas and glassware are kept clean and tidy. Conduct basic, daily equipment calibration. Troubleshoots minor issues and maintains equipment in good working order.
• Other 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.

WHAT YOU BRING TO THE ROLE

• 1-2 years in a Pharmaceutical Analytical testing lab.
• Bachelor’s degree in science, chemistry, biochemistry or other related field required.
• Analytical Wet Chemistry Lab experience using the following methods/equipment; titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays.
• High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment.
• Excellent communication skills both verbally and written.

COMPETENCIES REQUIRED FOR THE ROLE

INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad 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.

Role Specific Requirements:

• Conducts analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases and water. ie pH, Conductivity, TOC, Viscosity, Potency tests.
• Samples and performs identity testing on raw materials according to the schedule or as requested, utilizing approved sampling techniques for QC and Microbiology.
• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
• Prepares samples for analysis according to company SOPs & GLP methods.
• Performs specific analytical tests utilizing HPLC, GC, UV, IR, FTIR and other instruments.
• Analyzes data, keeps the supervisor informed of discrepancies, deviations, out of specifications (OOS) and unusual trends as they occur.
• Inform QC Supervisor to ensure that all reagents and supplies are replenished in a timely manner.
• Ensures work areas and glassware are kept clean and tidy. Conduct basic, daily equipment calibration. Troubleshoots minor issues and maintains equipment in good working order.
• Other duties as assigned