Job Description
Job Description
Description:
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The Quality Engineer is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics.
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This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include the Product QA, Manufacturing QA,
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Supplier/Incoming QA, Process Qualification/Validation, Compendia management and CAPA.
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This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with local, Corporate, and governmental regulations.
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Particular focus on process qualification PPQ support and review activities on range of topics from process controls to raw material controls.
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Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.
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Assist project teams in planning, preparation, review and approval of quality documentation.
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Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures.
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Apply effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
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May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
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Support the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs. Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
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Support new product introduction for pharmaceutical products, medical devices, or combination products.
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Support design changes to existing medical devices and combination products.
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Interact with internal and external partners for development of best practices in our quality systems and procedures.
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Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
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Oversee the implementation and management of training and education programs for various aspects of quality assurance.
Qualifications:
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BS Degree
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5 years relevant experience
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Experience with manufacturing QC review
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Experience in process validation/Qualification
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Must have Experience with validating documents
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Biologic manufacturing- medical devices or Biologic
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.