Job Number: 21-14377
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Technical Writer for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments.
- Ability to interview cross functional subject matter experts and translate their description into actionable instructions- Work Instructions, Job Aids using the templates prescribed by corporate policy.
- Schedule cross functional team meetings, collect feedback, create draft documents, post on sharepoint, schedule reviews, collect and resolve feedback.
- Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
- Prepare SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
- Work independently but recognize need to consult stake holders and keep them informed of progress.
- Identify and lead improvement efforts within current procedures.
- Maintain a good understanding of ICH Guidelines, regulations and other guidelines applicable to GMPs.
- Ability to negotiate and influence solutions without direct authority.
- A self-starter with an ability to manage electronic systems with minimal training and supervision.
- Minimum of 5-8 years’ experience in a GMP laboratory environment. At least 5 years’ experience in writing and reviewing standard operating procedures.
- Experience with microbiology testing is a plus.
- Demonstrated ability to successfully manage competing deadlines and balance priorities.
- Excellent technical writing skills, close attention to detail and excellent follow up.
- Expertise in Microsoft Word and SharePoint.
- Proficient in Microsoft outlook, MS team meetings, SharePoint, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.