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Quality Assurance Analyst

2 months ago

Beverly, United States LaunchWorks, LLC. Full time
Job DescriptionJob Description

LaunchWorks is seeking a Quality Assurance Analyst to join our team In this role, you will be an integral part of our quality team and play a direct role in covering most areas of our overall quality system. We offer a flexible work environment where after completing the onsite training program, you'll have the option to enjoy a hybrid work arrangement. If you have a proven track record of improving QMS processes within an ISO environment and are ready to make a difference and build your career in a dynamic and rapidly evolving field, look no further

ABOUT OUR COMPANY: As a contract development and manufacturing organization, LaunchWorks drives advancements in diagnostic life science tools available to scientists, doctors, and patients. The company develops and manufactures products consistently, exactly, and reliably to client specifications while meeting applicable quality and regulatory requirements. We believe in supporting our customers’ development and manufacturing needs so that they can focus on their science.

Our people are their greatest asset. They are a winning team of innovative, passionate, and knowledgeable experts with a track record of turning complex life science ideas into high-quality products. As a CDMO, our company is committed to optimizing every step of the manufacturing process to create high-quality diagnostic products for customers that reach the market and the people who need them safely and quickly. As an employer, we believe in fostering the unique talents of employees and recognizing hard work and teamwork to achieve the company’s mission.

“I love working at Launchworks because it’s a great balance of coming in to work while enjoying the culture around you to get that work done.” – Amanda, Quality Assurance Specialist

“I enjoy working for Launchworks because it is a dynamic and fast paced environment. At Launchworks I am continuously learning new technology and applications for the products we make. Above all, the culture at Launchworks truly allows you to grow into a position with the responsibilities you want out of it.” – Kait, Application Scientist & Principal Investigator

HOW YOU WILL CONTRIBUTE (Overall & Key Responsibilities):

As a Quality Assurance Analyst I, you will be responsible for knowledge and coverage of most areas of the overall quality system at Launchworks and will play a direct role with: ECO (Electronic Change Orders) processing, deviation processing, rework processing, batch record review and product release, authoring and review of documents and creation of Certificate of Conformance (C of C) and Certificate of Analysis (C of A) to customers on an as need basis. You will lead and manage the process improvements for the ECO Process, eQMS and other parts of LaunchWorks QMS and lead and manage Customer Tech Transfers and efforts to continually improve the process while adhering to ISO and regulatory requirements. In addition, you will play a role in document change requests, scanning and filing of quality records and archiving batch records for on and off site. You will also attend meetings and assist in audits as necessary assuring Quality guidance are being met per SOP ISO 13485(current revision).

  • Tech Transfers: Lead and manage the Tech Transfers process for customer requirements that will adhere to ISO, GMP and regulatory requirements. Will lead and manage efforts to continually improving the process by working with other department to determine feasibility, implementation, and completion.
  • Documentation Author, Reviewer and Reviser: Serves as an author or reviewer and revise documents as needed. Reviews documents from a QA perspective and making documents effective in eQMS mostly including label spec sheets, formulation work instructions, COC/COA.
  • Upstream ECO Processing: Receive any requests for an Engineering Change Order (ECO) through eQMS. Help review ECOs against Bill of Material and Customer Requirements when applicable. Keep track of all current ECO to ensure they are processed in a timely manner along with the Onboarding department. Approve and close ECO, as appropriate, by making parts and documentation effective in eQMS and ERP. Send email out to team once ECO has been approved.
  • Upstream Binder Release: Review batch records once received from Onboarding. Verify correct ERP part revision and BOM is in the binder with approved ERP related jobs. Add any new or existing deviations or NCMRs that pertain to the batch record being released. Sign off as approval QA approval allowing production to begin the build.
  • Downstream Product Release: Review of all paperwork in a batch record binder once received from Production. Review for completion of all fields, accuracy, and legibility per Good Documentation Practices. Verify customer approval has been obtained with passing QC results when applicable. Enter all released material in the ERP system for release to by shipped and create any applicable COC/COA. Perform final sign-off and filling of batch record binder. Email all the product release email recipients about lot release status.
  • COC/COA Processing: Create Certificate of Conformance (COC) and Certificate of Analysis (COA) through templates when releasing batch records. Includes the correct information for the COC/COA from the Batch Record. Includes COC/COA in the batch record and product release email.
  • Deviation Processing: Process deviations when received in eQMS when applicable. Keep track of all current deviations to ensure they do not pass their expiration date. Close deviations as appropriate through a document change, CAPA, ECO, or otherwise. Make copies of all deviations and file them in the appropriate batch records.
  • NCMR, CAPA and Complaints Processing: Will assist with NCMR, CAPA and Complaints processing when required. This will includes investigations, closure, metrics, and completion.

WHAT YOU NEED TO SUCCEED (Minimum Qualifications):

  • Associates or Bachelor’s degree in Life Sciences, Chemistry, Biology, Molecular Biology or Biochemistry
  • Minimum 1 year in manufacturing or QC environment / lab experience.
  • Microsoft Office
  • ERP/ PLM/ /EQMS/or Electronic Batch Records software is a plus.
  • Proven track record of improving QMS processes within an ISO environment.

WHAT WILL SET YOU APART (Competencies)

  • Attention to detail
  • Ability to multi-task and change priorities as needed
  • Strong communication skills and command of the English language
  • Strong organizational skills
  • Attention to detail

WHY JOIN US:

At LaunchWorks, we strive to offer a comprehensive benefits package that helps you and your family maintain health and well-being -both physically and financially. Our comprehensive benefits package includes:

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Health Savings Account (HSA)
  • Flexible Spending Account (FSA)
  • Voluntary Accident, Critical Illness, and Hospital Indemnity Insurance
  • Basic Life and AD&D / Voluntary Life and AD&D
  • Short-Term Disability
  • Long-Term Disability
  • Pet Insurance
  • Commuter Transit Benefits
  • 401(k) Retirement Plan w/Safe Harbor Employer Contribution
  • Paid Holidays
  • PTO

It is LaunchWorks policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.