Document Reviewer II - QA - Afternoon

JOB DESCRIPTION

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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 . Verif y and confirm the integrity and traceability of all data generated and reported.

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 . 

• Review and approve TrackWise OOS/DRs generated by laboratory

• Release Raw Material and Packaging Components in SAP

• Release of P roduct C ertificate of A nalysis using applicable LIMS software

• Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists /chemists. 

• Verif y 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. 

• Notif y 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. 

• P erform 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.

Standards and Expectations:  

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives . Carry out all duties within strict compliance to Patheon quality SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times . Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner .   Consistently strives to improve skills and knowledge in related field .   

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: s afety 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–$70,000.00.