Technical Writer I – Operations

at  Thermo Fisher Scientific

SUMMARY:

Prepare and revise Standard Operating Procedures (SOPs) based on Deviation Reports(DR)/ Corrective Action Preventative Action (CAPA) and Change Control (CC) initiatives within the operations department. Assist Production Management (Processing or Packaging) groups through completion of administrative tasks as assigned.

EDUCATION:

College/Technical School diploma in pharmaceutical manufacturing, science or related field.
Bachelors of Science or Bachelor of Applied Science or related field an asset

EXPERIENCE:

2 years of related pharmaceutical experience, preferably in a Manufacturing environment
Previous experience leading training in the pharmaceutical industry (an asset).
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

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.

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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally

Quality Documents

• 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. In particular, procedures in response to Bi-Annual Reviews, DRs, comments/audits by clients and regulatory agencies, change controls (CCs), new/modified equipment, and general changes in procedures
• Ensure procedures/SOPs are regularly reviewed and kept up to date with proper approvals
• Work closely with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided
• Work closely with Technical Operations, PPT Engineers and processing and packaging departments in the generation and approvals of SOPs and CCs.
• Work closely with quality and investigations to understand requirements for each CAPA/DR/SOP.
• 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 back up 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.

Metrics

• Collect and analyze Operations Administration metrics and identify potential projects/solutions