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Job Description:
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
Reviews and approves Quality, Quality Control, Validation and Automation related documents
Review and approves Standard Operating Procedures (SOPs).
Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
This position will regularly interact with: Reporting Manager
Sometimes will interact with departments listed below: Quality Control, Manufacturing Operations, Manufacturing Engineering, Manufacturing Science and Technology (MS&T), Validation, Site Engineering, and Digital Plant
Qualifications:
Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
Preferred Active member of ASQ or ISPE.
Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment
Able to interpret complicated data and make sound decisions, Independently
Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality.
Prior experience of QC equipment Qualification and some project management experience
Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.
Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.
Excellent Technical writing and oral communication skills are required.
Background in problem solving
Knowledge of Data integrity principles
Proven attention to details
Comfortable working in an FDA regulated environment.
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.
Full Time
Wholesale
$94k-118k (estimate)
06/23/2024
08/22/2024
synectics.net
LEBANON, OH
25 - 50
1993
HEIDI BALE
<$5M
Wholesale
Environmental Synectics, Inc. (Synectics) is a HUBZone certified small business enterprise with more than 25 years of experience providing environmental services, information technology services and advisory & assistance services to federal government agencies as well as commercial and Fortune 500 companies. Since our founding in 1993, we have successfully executed work for the U.S. Air Force, Army and Navy at scores of installations nationwide. Synectics architected and implemented the environmental industrys most versatile cloud-based data management system with integrated Automated Data Rev...iew (ADR) capabilities. Our Environmental Data Management System (EDMS) requires only a secure internet connection to allow project teams around the globe access to datasets, report generation capabilities, and communication with colleagues. Synectics EDMS provides comprehensive functionality to all environmental projects and is backed by a team of professionals committed to leveraging innovative technologies to optimize processes, reduce costs and shorten schedules for the benefit of our clients.
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