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Synectics Inc. · 1 week ago

QA Specialist- Risk Management (or Senior QA Associate)

Worcester, MA

Contract

Onsite

Mid, Senior Level

3+ years exp

Synectics Inc. is seeking a QA Specialist to support quality risk management activities related to biologic drug substances. The role involves collaborating with technical experts, documenting evaluations, and monitoring risk management processes to ensure compliance and continuous improvement.

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Responsibilities

Supports activities and initiatives of the quality organization to implement and manage the quality risk management activities as well as leading different QRM related job tasks

This role will document evaluations relevant to commercial product risk for biologic drug substances, general site risk, risk associated with cross contamination, facilities, utilities and equipment risk as relevant to assigned responsibilities

Working knowledge of ICHQ9, and Annex 1 helpful

The primary responsibilities will be collaborating with technical experts to update risk management documentation and ensure timely periodic review of risk documents and assist in revision when appropriate

Provide project support to the Cross Functional Team and help to facilitate risk documentation as needed for projects related to risk, continuous improvement, or investigations

Monitor and track open action items from the quality risk management activities, ensure they are implemented as required

Monitor periodic review, obsolete documents as necessary, maintain risk documentation and updates

Analyze data from multiple sources to identify common trends and identify areas for improvement

Prepare reports to document the outputs of risk management monitoring activities, if required

Escalate Risk- Use sound judgement to identify novel events, new risks or changes to the risk profile, make recommendations to escalate or provide rationale why escalation is not necessary

Support QA Compliance activities as needed ( Investigations, audits, etc.)

Qualification

GMP experienceRisk ManagementQA experienceBiologics knowledgeScience backgroundEffective communicationCross-functional teamwork

Required

Bachelor degree in Science

3-5 years of GMP experience, preferably in Biologics, risk management experience beneficial

Effective verbal and written communication skills

Science related background

Background in GMP manufacturing

Experience in a QA role

Experience in Risk Management

Ability to work with cross-functional teams

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.