Description:

• Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments.

• Schedule cross functional team meetings, collect feedback, create draft documents, post on sharepoint, schedule reviews, collect and resolve feedback.

• 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.

Qualifications:

• 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 Veeva EDMS preferred, or similar

• Experience with ERP, SAP Preferred, revising or creating new documents

• Experience working cross functionally, communication and customer service skills.

• 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.

• Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.

• Ability to negotiate and influence solutions without direct authority.

• A self-starter with an ability to manage electronic systems with minimal training and supervision.

• 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 Share Point.

• Proficient in Microsoft outlook, MS team meetings, Share point, EDMS.

• Able to conduct video conference calls via MS teams 4-6 hours a day.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.