Description
Technical Writer (Bloomington, IN)
Our client in the medical devices/ life sciences/pharma space, is currently in need of a Technical Writer for a large project re-writing SOP's from IBM to Blue Mountain. Role is a Contract, there is not a timeline or capped end date, however, this project is expected to take 3-6 months. Technical Writer will need to sit onsite in at the client's facility in Bloomington, IN, as proprietary information the writer will need to access is not permitted to leave the site. Technical Writer who knows life sciences that has not worked with Blue Mountain may be considered. All experience levels will be considered for this position, a great worker that is a self-starter (can research and figure things out, etc.) with 1-2 years' experience may be considered.
More about this role:
The Technical Writer (temp) in the Calibration Department is primarily responsible for developing Standard Operating Procedures utilizing equipment/system/instrument or calibration software operating manuals, instrument specifications, etc. This candidate will sit onsite at the Bloomington facility and report to the Calibration Manager.
The responsibilities:
Collaborate with cross-functional teams including engineers, scientists, regulatory specialists, and product managers to gather and interpret technical information. Implement feedback from technical teams to improve document integrity and quality.
Ensure documentation complies with industry standards and regulatory requirements, such as FDA regulations and ISO standards.
Develop the scope and devise an approach for assigned standard operating procedures.
Identify sources and stakeholders and collaborate to author standard operating procedures.
Determine the appropriate information sources to be used and obtain the required procedural steps.
Author procedures and collaboration with stakeholders for initial review or acceptance.
Submitting finalized SOPs in the electronic system for final approval and issuance.
Manage multiple SOPs at any given time.
Required qualifications:
Skills: Technical Writing, Writing SOP's, Regulatory Compliance, Documentation Development, Collaboration and Communication. Previous experience with Blue Mountain a huge plus!
Experience developing high-quality documentation including user manuals, SOPs, and engineering reports for medical devices and/or pharma/ life sciences. The right candidate that does not have industry experience with Blue Mountain experience may be considered.
Minimum 1 to 2 years' technical writing experience, preferably in the pharmaceutical industry. All experience levels will be considered.
Critical & creative thinking and problem-solving skills.
Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP) strongly preferred.
Client is a leader in providing contract development and manufacturing services to the biopharmaceutical industry. The company is renowned for its innovative solutions and commitment to quality, offering a collaborative and dynamic work environment that fosters professional growth and development. Why be a Technical Writer here? This position presents an exciting opportunity to engage with cutting-edge biopharmaceutical processes and contribute to impactful healthcare advancements.
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