Quality Assurance (QA) Specialist - Synectics : Job Details

Job Responsibilities:

• This position provides assurance of adherence to documentation standards and principles.
• The role is primarily responsible for managing the creation and revision of Quality System and processes documents including assessment of proposed changes taking all controlled documentation and processes into account.
• Acts as Subject Matter Expert for Quality documentation administration (Change Control) and is the interface between RDQA QS Documentation Management group and supported R&D functions.
• Provides client with understanding of the Quality System and its practical application.
• Participates in global compliance and continuous improvement projects related to Quality System documentation.
• Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.
• Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
• Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
• Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM)
• Maintains notifications, relations, and other property information within the Document Management System (DMS).
• Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.
• Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.
• Collects and reports documentation-related key performance indicator metrics.
• Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).

Qualifications:

• Bachelor's degree (technical/scientific area preferred) or equivalent experience.
• Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems
• 1-2 years' experience using and administering electronic document management tools.
• Basic understanding and knowledge of GxP requirements and pharmaceutical regulations preferred.
• Advanced knowledge and hand-on experience with Document Management Systems OR other database applications
• Advanced organizational skill, attention to detail
• Experience with Microsoft Office products, incl MS Word processing / formatting experience
• Advanced spoken and written English skills (OUS only))
• Excellent verbal and written communication and interpersonal skills
• Strong independent contributor and team member in a fast-paced environment.
• Ability to work effectively in a team environment.
• Builds strong relationships with peers and cross-functional partners to enable timeline completion of document lifecycle.
• Detailed oriented with solid problem-solving acumen.

California Fair Chance Act:Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/. 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.