What are the responsibilities and job description for the QA Engineering Specialist position at Synectics?
Position Summary :
- This role is responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility.
- This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
- QA lead on technology transfer activities (process) :
- Ensure technology transfers on new product introduction and / or new trials and cohorts are compliant with internal standards and / or regulatory requirements, as applicable.
- Maintain knowledge of scientific literature, regulatory guidelines, internal standards / procedures and apply key concepts during project activities / plans.
- Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
- Interact and collaborate with cross-functional teams to achieve common goals.
- Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.
- Support Product / Program Lifecycle Management Activities
- Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
- Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
- Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
- Review media simulation activities to ensure successful execution and documentation.
- Maintain data integrity by ensuring procedures / processes are compliant with internal data integrity standards and procedures.
- Work with Engineering / Facilities / Warehouse / Supply Chain / Manufacturing Operations / Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
- Ensure procedures are adequate to review and confirm appropriateness of data.
- Display Leadership Qualities
- Create an environment of teamwork, open communication, and a sense of urgency
- Promote a mindset of continuous improvement, problem solving, and prevention
- Drive strong collaboration within the site and across the network
- Build trust and effective relationships with peers and stakeholders
- Drive improvements to remove inefficiencies, improve quality and optimize productivity.
- Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
- Reporting Relationship : Reports to Senior Manager, QA Engineering
Qualifications
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.
