Job Description:
- Assist PDM Compliance Lead responsible for managing and delivering the harmonization and integration of documents acquired through acquisitions by applying document management and technical transfer business standards using appropriate document management systems and corporate training systems, perform QC of Standard Operating Procedures/Business Practices/Job Aids, assist with authoring/revising described documents to meet PDM quality standards.
- PDM document integration activities:
- Collaborate with colleagues across PDM regulated groups, as needed, to track and manage key deliverables.
- Manually transition documents to target application including meta data for mapping of content
- Revise SOPs for consistency with template
- QC of content and confirmation in target application
- Assist SOP & Training Administrators with document approval workflows and training course creation
- Generation of best practices and/or job aids, including transition to target application with meta data for mapping of content
- Additional duties relevant to the harmonization and integration may be requested
- Collaborate with PDM regulated colleagues from bioanalytical, systems, and compliance groups across Andover MA, Groton CT, and Bothell WA sites.
Qualifications :
- BS 6+ years; MS 4+ years
- Expertise in document management systems, administration of training systems, and project management.
- Knowledge of GLP/GCLP operations, regulatory requirements and familiarity of GDMS, Gnosis and administration of My Essential Learning are critical to support integration activities.
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.