Work Schedule
Weekend days
Environmental Conditions
Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Summary:
Responsible for reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory. Verify and confirm the integrity and traceability of all data generated and reported.
This role is a weekend shift position. The schedule is Thursday-Monday 9:30am-6:00pm.
Essential Functions:
- Review all regular technical documents (e.g., batch testing, stability testing, method development and validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time.
- Release Raw Material and Packaging Components in SAP
- Release of Product Certificate of Analysis using applicable LIMS software
- Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists.
- Verify the integrity and traceability of all data generated and reported.
- Follow up with scientist/chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standards.
- Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
- Write/Update SOPs and initiate change control when necessary.
- Adhere to assigned schedules and standard times.
- Maintain a safe working environment and report potential hazards.
- Perform alternating or rotating shift work (as required).
REQUIRED QUALIFICATIONS
Education:
- Bachelor of Science in Chemistry or related science.
Experience:
- Minimum 3 years of previous pharmaceutical analytical development experience.
Equivalency:
- Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
- Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, and titration.
- Knowledge in Empower, LIMS Nugensis and Trackwise software.
- Excellent written and oral communication skills.
- Good working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements.
- Strong organizational skills and detail oriented. Ability to meet deadlines and prioritize.
- Demonstrated computer proficiency with Microsoft Office programs.
- Proficiency with the English Language.
Physical Requirements:
- Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.
Compensation
The estimated annualized pay range for this position in Ontario is $50,800.00–$76,150.00.
