QA lead technical operations

2 days ago

Devens, United States Synectics Full time

Job Description:

  • 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.
  • 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
  • Will interact with departments listed below:
    • Quality Control
    • Manufacturing Operations
    • Manufacturing Engineering
    • Manufacturing Science and Technology (MS&T)
    • Validation
    • Site Engineering
    • Digital Plant
Qualifications :
  • B.S in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
  • Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8-10 years focused on product quality.
  • Preferred Active member of ASQ or ISPE.
  • 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, Track Wise, 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
  • Will deal with electronic batch records- needs to have quality software/programming exp
  • Comfortable working in an FDA regulated environment.
  • Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)


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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