QA lead technical operations

6 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 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
  • 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.

  • QA lead technical operations

    5 days ago

    Devens, United States Axelon Full time

    Job Description: QA Lead Technical Operations, Projects Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Job Description/ Responsibilities: - Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and pproval of Investigations and Corrective Actions. - Decision making of non-conformance...

  • QA lead technical operations

    6 days ago

    Devens, United States Axelon Full time

    Job Description: QA Lead Technical Operations, Projects Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Job Description/ Responsibilities: - Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and pproval of Investigations and Corrective Actions. - Decision making of...

  • QA Lead Technical Operations MA

    4 days ago

    devens, United States Axelon Services Corporation Full time

    Job Description: QA Lead Technical Operations, ProjectsOnsite, Devens locationWork Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/ Responsibilities:- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andapproval of Investigations and Corrective Actions.- Decision making of non-conformance...

  • QA Lead Technical Operations MA

    4 days ago

    devens, United States Axelon Services Corporation Full time

    Job Description: QA Lead Technical Operations, ProjectsOnsite, Devens locationWork Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/ Responsibilities:- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andapproval of Investigations and Corrective Actions.- Decision making of non-conformance...

  • Lead Projects QA Technical Operations

    7 days ago

    Devens, United States Cynet Systems Full time

    Job DescriptionJob DescriptionWe are looking for Lead Projects QA Technical Operations for our client in Devens, MAJob Title: Lead Projects QA Technical OperationsJob Location: Devens, MAJob Type: ContractJob Description:Pay Range: $63hr - $66hrResponsibilities:Provides Quality Assurance support to Devens Site and reporting Manger through quality...

  • QA Lead Technical Operations, Projects

    4 months ago

    Devens, United States Omni Inclusive Full time

    QA Lead Technical Operations, Projects Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Job Description/ Responsibilities: • 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...

  • QA Operations Lead

    6 days ago

    Devens, United States Primary Talent Partners Full time

    Primary Talent Partners has a 6-month contract opening for a QA Lead Technical Operations Specialist with a client of ours in Devens, MA. This role is 100% onsite. Duration: 6-month W2 contract, no PTO or benefits Pay: $61 - $66.39 Job Title: QA Lead Technical Operations, Projects Location: Devens, MA Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)...

  • QA Lead Technical Operations

    3 days ago

    Devens, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: 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...

  • 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...

  • QA lead technical operations

    5 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...

  • QA lead technical operations

    1 week ago

    Devens, United States Synectics Inc Full time

    Job DescriptionJob DescriptionJob 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 expectationsReviews and approves Quality, Quality Control,...

  • QA Manufacturing Operations Lead

    5 days ago

    Devens, United States LanceSoft Full time

    Job Title: QA lead technical operations Location: Devens, MA 01434 Duration: 6 months Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision...

  • QA Lead Technical Operations

    7 days ago

    Devens, United States Actalent Full time

    Great opportunity to get your foot in the door with one of the top Biopharmaceutical companies in the Devens, MA area! If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com. Description Work Schedule: Mon - Fri First shift 8:30AM - 5PM Job Description/ Responsibilities: Provides Quality Assurance QA support to...

  • Axelon Services Corporation | QA Lead Technical Operations MA | devens, ma

    5 days ago

    devens, United States Axelon Services Corporation Full time

    Job Description: QA Lead Technical Operations, ProjectsOnsite, Devens locationWork Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/ Responsibilities:- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andapproval of Investigations and Corrective Actions.- Decision making of non-conformance...

  • QA Operations Specialist

    2 weeks ago

    Devens, United States Joulé Full time

    Job Title: QA Operations Specialist Location: Devens, MA Hours/Schedule: Monday to Friday, 7AM - 3:30PM Type: Contract, Potential for extension or conversion to permanent Responsibilities Perform QA on the floor activities. Ensure manufacturing compliance with applicable procedures and batch records. Perform real time review of manufacturing batch...

  • Field Specialist QA Operations

    3 weeks ago

    Devens, United States Sunrise Systems, Inc. Full time

    Job Title: Field QA Specialist Job ID: 24-05259 Location: Devens, MA, 01434 Duration: 12 Months contract on W2   This role is 100% Onsite Work Schedule: Mon - Fri, 07:00 AM - 03:30 PM EST Holidays required as needed   JOB SUMMARY   Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility...

  • Axelon Services Corporation | QA Lead Technical Operations MA | devens, ma

    2 days ago

    Devens, MA, United States Axelon Services Corporation Full time

    Job Description: QA Lead Technical Operations, ProjectsOnsite, Devens locationWork Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/ Responsibilities:- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andapproval of Investigations and Corrective Actions.- Decision making of non-conformance...

  • Technical Operations Lead

    6 days ago

    Devens, Massachusetts, United States Joulé Full time

    About Joulé">Joulé, a forward-thinking company, offers a dynamic environment for professionals to thrive. As our ideal candidate, you will be part of a team that values expertise and innovation.">Salary: $120,000 per annum">We are seeking a highly skilled QA Technical Operations Lead to join our team in Devens, MA. This role is responsible for providing...

  • Field Specialist QA Operations

    3 days ago

    Devens, United States Volt Full time

    Innova Solutions has a client that is immediately hiring for a Field QA Specialist Position type: Full-time- Contract Duration: 12 Months Location: Devens, MA Shift: 5am to 5:30pm- Rotation shift (2 days On- 2 days off, 3 days On- 2 days Off and so on) As a Field QA Specialist you will:Perform QA on the floor activities.Ensure manufacturing compliance...

  • Field QA Specialist

    3 weeks ago

    Devens, United States Synectics Inc Full time

    Job DescriptionJob DescriptionDescription:Seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with our policies, standards, procedures, and Global cGMP. Functional...