QA Compliance Specialist

2 weeks ago

Indianapolis, United States Synectics Inc Full time
Job DescriptionJob Description

Description

  • The QA Compliance Specialist implements robust Quality Systems for Indianapolis considering and regulatory requirements of the organization.

  • This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections.

  • Supports the development and oversight of robust quality systems, including both implementation and operation at site level.

  • Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators

  • Works with the management team to implement and execute the Inspection Readiness program; including Corporate Inspections and Global Health Authority Inspections.

  • Facilitates training on all QA Compliance programs.

  • Supports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Global document assessments required to be performed at the site level.

  • Contributes significantly to the site inspection preparation, program management, response and commitment process.

  • Escalates high quality risks per procedure and supports agency notifications such as Field Alerts.

  • Performs duties as assigned to ensure compliance to global and local regulations.

  • Represent QA Compliance on project teams and in meetings.

  • Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.

  • Adheres to all GMP requirements.

Qualifications:

  • B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.

  • 8+ years of experience in a GMP Biopharmaceutical environment

  • 2+ years of related experience in a Quality Assurance role

  • Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues.

  • Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance.

  • Previous experience in QA Compliance including self-inspections, preferred.

  • Ability to apply a phase appropriate, risk-based approach to QA operational decisions.

  • Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.

  • Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus.

  • Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).

  • Strong follow-up and organizational skills.

  • Experience with radiopharmaceutical therapies a plus.

  • Direct experience reviewing and/or authoring standard operating procedures.

  • Ability to work well independently and within a team.

  • Excellent oral and written communication skills with technical writing experience required.

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.

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