What are the responsibilities and job description for the Documentation Specialist position at Synectics Inc.?
Job Summary
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.
- Review documents, review document change requests and route document change requests to process document creation, maintenance, and implementation in eDMS.
- Control/distribution of controlled documentation.
- Preparation of records for issuance to production.
- Organize and maintain the Document Control System to meet current regulatory requirements.
- Implement, control and coordinate changes in documentation.
- Facilitates the updating and routing of controlled documents, including, but not limited to, Governance and Procedure documents, Master Forms and Master Batch Records within the eDMS.
- Manage the change process for manufacturing documentation consisting of SOPs, policies, manufacturing documentation, specifications and other controlled documents.
- Review, edit and process changes to controlled documentation such as procedures, manufacturing records, forms etc. in an electronic document management system.
- Ensure proper approvals have been obtained prior to final release of document and coordinate effective dates with departments.
- Preparation of records for issuance to production.
- Coordination and maintenance of the periodic review system.
- With minimal supervision, complete special projects and routine work on schedule.
- Document Lifecycle: Involved end-to-end in the change control process.
- Proofreading site documents, standard operating procedures (SOPs), manufacturing documentation, batch records, forms, and specifications.
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- 3 years' experience in quality assurance, quality oversight or relevant experience.
- Experience in regulated pharmaceutical/medical device industry and document management areas preferred.
- Proficient in MS Office, Word and Excel.
- eDMS experience (Veeva Vault) preferred.
- Excellent proofreading skills. Excellent verbal and written communication skills.
- Good analytical, decision-making and problem-solving skills.
- Experience working in both team setting and independently.
- Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Excellent interpersonal skills.
- Ability to identify, communicate and follow through to completion action plans to resolve problems.
- Leadership Skills
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.