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Form of workJob Description
$30-$36 Hourly
Description:
Manage the documents created by the GMP Facilities Department to ensure that the documents are tracked and organized through the document lifecycle.
Respond to Customer requests in a professional and timely manner.
Respond in accordance to cGMP policies and procedures.
Train colleagues
Work with internal and external partners. Provide cGMP oversight of GMP documentation to ensure they are operating within the cGMP policies and procedures.
Demonstrates and promotes Values and behaviors.
Preparation and distribution of SOPs/WPs for signatures within electronic document management system; organizing, tracking status and timelines.
Assist in creating new procedures and providing input on existing for periodic reviews.
Support GMP Facilities SOP/WP Administration operations, including individual projects and assignments
Format technical document according to standard formatting and update of documents to incorporate Subject Matter Expert review comments.
Preparation of SOP/WP and supporting documents for submission to the Compliance Wire (training management system) Manager.
Track GMP Facility Department Quality Management System actions and provide status updates.
Assist in completing Instrument Data Forms to input new or revise instrumentation.
Assist in criticality assessments.
Responsible for maintenance of Excel spreadsheets for maintenance and tracking of SOPs/WPs.
Filing of equipment asset documentation and routine and demand work orders.
Complete and review documentation work orders to ensure cGMP good documentation practices and change control procedures are being followed
Qualifications:
AA / AS degree or acceptable trade certification from technical
Minimum 3 years document management experience
Minimum 3 years in the Pharmaceutical industry preferred
GMP document review and maintenance experience
Proficient in cGMP guidelines for documentation management in accordance with company policy and procedures
Expert written and verbal communication skills
Outstanding customer service skills
High proficiency in Microsoft Word, Excel and Outlook
Ability to meet schedules and timelines
Strong interpersonal skills
Must have strong organization skills, be a team player and be willing to work in an environment where individual initiative and accountability to projects are required
Must be able to work with limited day-to-day supervision
Must have a general knowledge of SOP standards
Must have experience with record retention, archival processes
Must have experience with electronic document management systems
Strong PC skills to include: Microsoft Excel and Word Excellent written and oral communication skills
Ability to work a minimum of a 40 hours work week
Ability to work safely when working alone or working with others
Ability to work within a GMP environment and properly gown according to room classifications and procedures
*******EQUAL OPPORTUNITY EMPLOYER******
*****COMPENSATION IS COMMISERATE WITH EXPERIENCE*****
Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.
Synectics is an Equal Opportunity Employer.
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.
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.
