What are the responsibilities and job description for the Manufacturing Quality Inspector position at Synectics Inc.?
Description
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.
- Laboratory Systems Operations (LSO) group is a key study team partner in the lab engagement process and plays a critical role in supporting Clinical Trials.
- For every clinical study, LSO assists with the development, review and approval of study specific documents based on study protocol.
- One of key documents LSO manages is a lab specification document which is a critical study start up document and provides sample collection, treatment, storage and shipment logistics for all patient sample types. LSO responsibilities include but not limited to:
- Oversee the production of Laboratory Systems Operations (LSO) deliverables for assigned clinical trials.
- Oversee all LSO timelines for assigned clinical trials and cross-functional meetings for assigned clinical trials.
- Coordinate discrepancy resolution efforts needed for complex issues that arise with the sample receiving team.
- Represent LSO team in vendor meetings to ensure timely response to projects and/or identified issues.
- Act as primary liaison with Regulated Bioanalysis, Biomarker Groups and Central Labs to ensure that priority project deliverables are met.
- Plans and manages LSO timelines for assigned clinical trials, specifically the completion of the Lab Specifications and Kit Delivery.
- Participates in vendor meetings to ensure proper representation for LSO and timely resolution of outstanding issues.
- Manages all process flows and data exchanges with any vendors or internal data providers/consumers.
- Assists with the development and review of trial-specific SOW, Laboratory manuals, Data mapping documents based on parameters supplied with MSA with applicable vendors and clinical protocol.
- Participates in cross-functional meetings where LSO tasks are discussed.
- Continually seeks to improve existing processes.
- Develops productive collaborations and communication with other cross functional groups.
- Ensures compliance with current SOPs. Participates in any internal quality assurance audits.
- Manages sample storage volumes and the sample lifecycle management process.
- Bachelor's degree in life sciences or equivalent field of study is required.
- Knowledgeable in clinical trials the end-to-end GLP, clinical study and sample lifecycle.
- 1-3 years of clinical study involvement and/or sample processing experience in a GLP regulated environment preferred
- Laboratory automation experience is a plus.
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.