The specific focus for this role is HPLC & MS analysis of cleaning verification samples, with some method development. To perform required analysis for the Pharmaceutical Development Services (PDS) Analytical Development ensuring that all Standard Operating Procedures (SOP), current Good Manufacturing Practices, current Good Laboratory Practices (GLP) and corporate quality standards are achieved. *Shift work required*
SPECIFIC JOB DUTIES
- To perform testing and assays in accordance to approved methods and SOPs
- All duties must be performed in strict compliance to all Pharma Services Group's (PSG) quality systems (SOPs, Good Manufacturing Practices).
- To document all experimental data in accordance with Good Manufacturing Practices and SOPs
- To recognize and report out of specification (OOS) results or deviations to Supervisor immediately
- To assist in method validation as directed
- To assist in trouble shooting and investigations as required
- To comply with all Environmental Health & Safety (EH&S) requirements and participate in EH&S training
- Shift work required. Typically 10hrs/day, 4 days/week, rotating in 7 days.
- Other duties as assigned
STANDARDS & EXPECTATIONS
In addition, every employee in PDS is expected to perform to the following standards:
- Be client and patient conscious at all times.
- Perform all duties in strict compliance with PSG Quality systems Standard Operating Procedures. Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintain the necessary compliance status required at your facility.
- Understand and support KPIs across your Function and Organization and actively engage in achieving excellent client service results.
- Represent the company positively and professionally through your conduct and behavior whether on site or when attending an off-site event.
- Perform all duties (whether routine or more complex) to the same high standard and in an efficient manner.
- Seek to establish excellent professional working relationships with clients and vendors.
- Interact professionally with PDS or Commercial colleagues, modeling appropriate team principles and partnering to meet project, functional and team objectives.
- Support continuous improvement within PDS. Identify and communicate potential areas for improvement in current procedures and assist in correcting problems.
- Appropriately communicate issues or risks in a timely and effective manner.
- B.Sc. in Chemistry, or related science.
- 1 to 3 years of previous related experience.
- Good understanding of basic chemistry, chromatography (eg High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), thin-layer chromatography (TLC) and spectroscopic technologies (eg Ultraviolet (UV), Infrared (IR).
- Good problem solving skills and logical approach to solving a scientific problems.
- Interest in improving their skills and knowledge in pharmaceutical development.
- Solid computer experience including lab software, Microsoft Word and Excel.
- Excellent written and oral communication skills.
- Legibility in documentation as per Good Manufacturing Practices requirement.
- Proficiency with the English Language.