Quality - QA Associate - Wednesday-Saturday - 11:00pm-7:30am

4 weeks ago

Bothell, United States On-Board Companies Full time
On-Board Scientific is hiring a Quality - QA Associate Specialist of Bothell, WA (Shift: Wednesday-Saturday 11:00pm-7:30am)
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position, Title, and State you are located.
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:
Position Type: Full Time/ 1 year with a possibility of extension
Job Location: Bothell, WA - Wednesday-Saturday Shift: 11:00pm-7:30am)
Benefits: 401K, Medical, Dental, Vision, and Life Insurance
Compensation: $40.40-$43.55 per hour.
Top Skills:
  • 1-3 years of GMP experience (QC, QA, or MFG)
  • 1-3 years Batch Record Review Experience
  • 1-3 years working in cleanrooms or other controlled spaces.
  • As a plus experience in quality systems such as deviations, CAPA, Change Control etc.
  • The Quality Associate II position plays a key role in supporting the cGMP quality operations based in Bothell. Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch records, and conducts walkthroughs of on the floor activities to ensure product and processes meet cGMP and internal standards. This role directly supports the facility release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment.
  • The primary focus of the QA Associate role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at Jump by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.

Responsibilities:
  • Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
  • May write and revise document control procedures including participating in the development and roll-out of document control tools.
  • Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
    • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
  • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
  • Generate document management system reports for Quality Council metric reporting.
  • Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
  • Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
  • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles.
  • Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
  • Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
  • Execute Quality operations in support of Manufacturing and logistics.
  • Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
  • Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
  • Oversee manufacturing operations during patient material receipt and drug product pack out.
  • May participate in revisions of Standard operating Procedures as needed.

Qualifications:
  • Bachelor's degree in relevant science or engineering discipline is preferred. A minimum of Associates degree and/or equivalent combination of education and experience is required.
  • 2-3 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are preferred.
  • Hands-on experience with batch record review and product disposition is preferred.
  • Strong computer skills with Word and Excel and other electronic manufacturing systems.
  • Detail oriented team player with effective planning, organization, time management and execution skills.
  • Proven experience working on teams where combined contribution, collaboration, and results were expected.
  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
  • Ability to work in a high paced team environment.
  • Strong written and verbal skills.


Apply Today
www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.

24-01378
INDOJ

  • Quality - QA Associate QA Associate

    1 month ago

    Bothell, United States Axelon Services Corporation Full time

    Job Description: Quality--QA Associate This is an Onsite role Work Schedule: Wednesday - Saturday, 6AM - 4: 30PM EST Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all...

  • Quality Assurance Specialist

    1 week ago

    Bothell, Washington, United States On-Board Companies Full time

    On-Board Scientific is looking for a Quality – QA Associate Specialist in Bothell, WAAbout Us: On-Board Services, Incorporated offers full-time positions with benefits including 401K.Position Details:Position Type: Full Time/ 6-months with a chance of extensionJob Location: Bothell, WA – Wednesday-Saturday Shift: 11:00pm-7:30amBenefits: 401K, Medical,...

  • Quality - QA Associate

    1 week ago

    Bothell, United States HonorVet Technologies Full time

    Job Title : Quality - QA Associate Job Location : Bothell, WA 98021 Contract: 6 Months on W2 Work Schedule: Sunday-Wednesday, 9PM - 7:30AM PSTJob Description : Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured...

  • Quality Assurance

    1 month ago

    Bothell, United States Spectraforce Technologies Inc Full time

    Title: Quality Assurance Specialist (Pharma ONLY - NON IT JOB) Duration: 06 Months Location: Bothell, WA *Schedule- 9:00pm - 7:30am, Sun - Wed** **Top Skills: - 3-5 years of GMP work experience - Familiarity with Batch Records - Deviations Experience Preferred - Associates or BA Degree preferred, or HS Diploma + relevant work experience -...

  • Quality - QA Associate

    4 weeks ago

    Bothell, United States Omni Inclusive Full time

    Shift Schedule is 2100-0730, Wednesday-Saturday The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch records, and conducts walkthroughs of on the floor activities to...

  • Quality - QA Associate

    1 month ago

    Bothell, United States HonorVet Technologies Full time

    Job Description: Shift Schedule is 2100-0730, Wednesday-Saturday The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch records, and conducts walkthroughs of on the...

  • Quality - QA Associate

    1 month ago

    Bothell, United States Omni Inclusive Full time

    Shift Schedule is 2100-0730, Wednesday-Saturday The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch records, and conducts walkthroughs of on the floor activities to...

  • Quality - QA Associate

    4 weeks ago

    Bothell, United States HonorVet Technologies Full time

    Job Description: Shift Schedule is 2100-0730, Wednesday-Saturday The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch records, and conducts walkthroughs of on the...

  • QA Associate

    1 week ago

    Bothell, United States Integrated Resources Full time

    Job Description: Job Title: QA Associate Location: Bothell, WA*100% onsite Work Schedule: Sunday-Wednesday, 9PM - 7:30AM PST* Top Skills - - Documentation Review experience - Scientific Degree - Experience working in a GMP environment *Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.* ...

  • QA Associate

    1 week ago

    Bothell, United States Collab Infotech Full time

    Job DescriptionJob DescriptionWe have an Immediate opening for a "QA Associate" with one of the Top 10 leading Pharmaceutical companies in Bothell, WA, for a 12 Months contract.    Job Description:Job Title: QA AssociateLocation: Bothell, WADuration: 12 Months Pay Rate: $34.96/hr on W2      Job Description:Job Title: QA AssociateLocation: Bothell,...

  • Quality - QA Associate

    1 month ago

    Bothell, United States Primary Talent Partners Full time

    Primary Talent Partners is searching for QA Associate to join our client's team in Bothell, WA . This role will be 12-month, full-time, W2 contract role with a high potential for extension and/or conversion. *** YOU MUST BE AUTHORIZED TO WORK IN THE US. *** THIS IS FOR A W-2 CONTRACT. WE ARE UNABLE TO SUPPORT C2C OR PROVIDE SPONSORSHIP. Job Description:...

  • QA Associate

    5 days ago

    Bothell, United States System One Holdings, LLC Full time

    Title: QA Associate Location: Bothell, WA Start Date: ASAP Schedule: Sunday - Wednesday, 9PM - 7:30AM PST Pay Range: $25 - 34.90/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs...

  • QA Associate

    1 week ago

    Bothell, United States Sunrise Systems Inc Full time

    Job Title: QA Associate Job ID: 24-02726 Location: Bothell, WA, 98021 Duration: 06 Months contract on W2 *100% onsite Work Schedule: Sunday-Wednesday, 9PM - 7:30AM PST* Top Skills - Documentation Review experience Scientific Degree Experience working in a GMP environment *Okay with candidates out of college who have a biology...

  • QA Associate || Pharma

    1 week ago

    Bothell, United States Synkriom Full time

    Job DescriptionJob DescriptionJob Title: QA AssociateLocation: Bothell, WA*100% onsiteWork Schedule: Sunday-Wednesday, 9PM - 7:30AM PST*Top Skills -- Documentation Review experience- Scientific Degree- Experience working in a GMP environment Company DescriptionFounded in 2015 and backed by two decades of hands-on experience, our strong insight on the...

  • QA Associate

    1 month ago

    Bothell, United States Aequor Technologies Full time

    Job Description: Quality--QA Associate This is an Onsite role Work Schedule: Wednesday - Saturday, 6AM - 4:30PM EST Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all...

  • QA Associate

    1 month ago

    Bothell, United States Sunrise Systems Full time

    Job Title: QA Associate Job ID: - Location: Bothell, WA, Duration: Months contract on W This is an Onsite role Work Schedule: Wednesday - Saturday, AM - :PM PST Top Skills - Documentation Review experience Scientific Degree Experience working in a GMP environment Maintains shop floor quality presence; disposition in-process...

  • QA Associate

    1 week ago

    Bothell, Washington, United States LanceSoft Full time

    Job Title: Quality - QA Associate Location: Bothell, WA 98021 Duration: 12 Months Schedule: PST, Wednesday-SaturdayTop Skills:1-3 years of GMP experience (QC, QA, or MFG) 1-3 years Batch Record Review Experience 1-3 years working in cleanrooms or other controlled spaces. As a plus experience in quality systems such as deviations, CAPA, Change Control etc....

  • QA Associate

    1 month ago

    Bothell, United States LanceSoft Full time

    Job Title: Quality - QA Associate Location: Bothell, WA 98021 Duration: 12 Months Schedule: 2100-0730 PST, Wednesday-SaturdayTop Skills: 1-3 years of GMP experience (QC, QA, or MFG) 1-3 years Batch Record Review Experience 1-3 years working in cleanrooms or other controlled spaces. As a plus experience in quality systems such as deviations, CAPA, Change...

  • QA Associate

    4 weeks ago

    Bothell, United States LanceSoft Full time

    Job Title: Quality - QA Associate Location: Bothell, WA 98021 Duration: 12 Months Schedule: 2100-0730 PST, Wednesday-SaturdayTop Skills: 1-3 years of GMP experience (QC, QA, or MFG) 1-3 years Batch Record Review Experience 1-3 years working in cleanrooms or other controlled spaces. As a plus experience in quality systems such as deviations, CAPA, Change...

  • QA Associate

    4 weeks ago

    Bothell, United States Sunrise Systems Inc Full time

    Shift Schedule is 21:00-07:30, Wednesday-Saturday Job Description: The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch records, and conducts walkthroughs of on...