Technical Writer I – Operations Specialist

3 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time

Job Summary:

We are seeking a highly skilled Technical Writer I – Operations to join our team at Thermo Fisher Scientific. As a Technical Writer I – Operations, you will be responsible for preparing and revising Standard Operating Procedures (SOPs) based on Deviation Reports (DR), Corrective Action Preventative Action (CAPA), and Change Control (CC) initiatives within the operations department.

Key Responsibilities:

  • Review, revise, and prepare procedures/SOPs for compliance to Good Manufacturing Practices (GMP) and to reflect current work activities in Operations department.
  • Ensure procedures/SOPs for Operations department are of sufficient detail for technical content, accuracy, clarity, completeness, and flow.
  • Work closely with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided.
  • Collaborate with Technical Operations, PPT Engineers, and processing and packaging departments in the generation and approvals of SOPs and CCs.
  • Track status of in-process SOPs, training, and other activities.
  • Create change controls.

Department Contributions:

  • Work with Operations Personnel to identify process improvements.
  • Attend key project meetings, client teleconferences, and on-site visits.
  • Support production department with logbook system, retrieval, and management for audits and storage purposes.
  • Act as a backup to any department coordinators.
  • Perform alternating or rotating shift work (as required).
  • Maintain a safe working environment and report potential hazards.
  • Maintain a personal project list of assignments with target completion dates.

Requirements:

  • College/Technical School diploma in pharmaceutical manufacturing, science, or related field.
  • 2 years of related pharmaceutical experience, preferably in a Manufacturing environment.
  • Previous experience leading training in the pharmaceutical industry (an asset).

Knowledge, Skills, and Abilities:

  • Knowledge of cGMP requirements, ability to follow Standard Operating Procedures (SOPs), and pharmaceutical processing regulations.
  • Strong team building and organization skills.
  • Excellent computer skills, including the ability to develop spreadsheets, presentations, and reports.
  • Excellent written and oral skills.
  • Detail-oriented and organized, with a high degree of accuracy and thoroughness.
  • Excellent interpersonal skills.
  • Proficiency with Microsoft Office.
  • Proficiency with the English language.

Standards and Expectations:

  • Follow all Environmental Health & Safety Policies and Procedures.
  • Work collaboratively with fellow team members, modeling 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:

  • Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations.
  • Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time.
  • Manipulation (lift, carry, move) of light to medium weights of 10-35 pounds.
  • Arm, hand, and finger dexterity, including ability to grasp and type for prolonged periods of time.
  • Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time.
  • Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

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