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Quality Engineer
3 months ago
Job Responsibilities: Provide interpretation, guidance, and training for clients regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization.Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, Qualification and Validation.Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).Support CAPA activities related to validation and qualification.Provide guidance, direction, and support to peers. Qualifications :Requires a 4 year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology.Technical science and/or engineering educationExperience in life sciences industry, preferably in pharmaceutical GMP and/or GDP regulated environmentExperience with pharmaceutical qualification/validation processes, preferably with shipping, equipment and/or facility qualification/validationExperience writing technical reports and quality system proceduresExperience writing, coordinating and executing qualification/validation activities (including validation plans, protocols, summary reports)Minimum of 4-7 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation or compliance.Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.).Excellent communication capabilities and teamwork capacities.Proven ability to work in a global environment and on virtual teams.Required Skills: Developing Procedures; Validation; Risk Assessment; Technical PMHybrid 3 days onsite, 2 days remote 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.
