Clinical Label Quality Associate
Synectics Inc.
North Chicago, IL
- Expired: over a month ago. Applications are no longer accepted.
Job DescriptionCompany Description
Description:
- Creating and approving labels for Clinical Supplies used in Clinical Studies.
- Compares different source documents and ensures that the information is consistent and accurate with the clinical label.
- This position requires use of a design program to create the .pdf proof of the label design.
- Implementing and maintaining the effectiveness of the quality system; reviews, proofreads, and approves Clinical Labels for accuracy and compliance to regulatory requirements.
- Reviews labeling for consistency with similar or related product labels.
- Communicates and coordinates labeling and documentation approvals with worldwide affiliates. Interaction and professional communication with business partners around the world is required.
- All communication is in English.
Qualifications:
- Bachelor�s Degree or equivalent experience (4+ years) is required, preferably in Science, English, Business, or related field to ensure accuracy of highly technical information used by Clinical Operations and regulated by the FDA
- Knowledge of regulations and standards a plus
- Ability to problem solve, manage multiple projects simultaneously, influence internal and external groups and provide leadership
- Strong organizational and human relations skills to deal with various levels of individuals and functional areas within the division
- Previous experience working within a change control system is helpful
- Labeling and documentation for clinical supplies must be completed accurately and within the designated timelines
- Must have strong organizational and clear communication skills
- Project management and QA experience nice to have
- Team oriented, keen attention to detail, willing to change priorities to help team
- Must be able to rearrange priorities on short notice to react to business needs
- Self-driven and comfortable working with a diverse group of business partners
- Experience with reading clinical study protocols, editing documents, quality assurance, project management
- Basic to Intermediate skills with computers (Individual will be required to use Smartsheet, an electronic inventory and label design systems, and must be able to quickly learn how to navigate)
- Prefer 2-3 years of experience in GMP or regulated industry
Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States. We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling. We also seek to justify our clients’ expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day. Our success has depended on our consistent ability to achieve both of these goals.
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.
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.
Synectics Inc.
Address
1 N Waukegan Road AP15
North Chicago, IL
USA
Industry
Healthcare
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