Reference Standard Coordinator

2 months ago

Whitby, Canada Thermo Fisher Scientific Full time

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), No eye contacts allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

**Summary**:
Handle the daily operation of the reference standard program in Lab Operations.

**Essential Functions**:

- Coordinate with Lab Operations to ensure timely qualification and requalification of Reference Standards or Reference Materials.
- Responsible for proper storage and inventory control of Reference Standards or Reference Materials in the designated secure area
- Responsible for maintaining reference standards in SampleManager LIMS
- Purchase, store, and handle Reference Standards from compendia sources for routine use according to compendia instruction under the supervision of Lab Operations.
- Request Reference Standards or updated Certificate of Analysis from client
- Maintain inventory and list of Reference Standards and Materials.
- Maintain Certificate of Analysis for All Reference Standards
- Distribute Reference Standards and Reference Materials to users, such as Laboratory Scientists
- Send notifications to Project Leader when the inventory is low.
- Dispose of remaining quantity of Reference Standards or Reference Materials from the designated secure area when the requalification is discontinued.
- Attend project kick off meetings.
- 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, biology, pharmacy or related field.

**Experience**:
Minimum 3 years of previous Pharmaceutical experience.

Previous experience with Stability Studies, Sample Tracking, Reference Standards, Controlled Substances, Training Records, Purchasing, Specifications, Certificates of Analysis or Laboratory Assistant Related Duties.

**Equivalency**_:_

Equivalent combinations of education, training, and relevant work experience may be considered.

**Knowledge, Skills**,** and Abilities**:
Strong organizational skills and detail oriented. Ability to work with little supervision. Ability to prioritize multiple tasks. Familiarity with Good Manufacturing Practices. Demonstrated Computer proficiency with Microsoft Office programs (e.g., Outlook, Excel, Word), PowerPoint). Ability to meet deadlines and prioritize. 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 systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and adhere to departmental systems 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. Model 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 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 occasionally.

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