Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 3 days ago

Quality Assurance Specialist II

thermofisher2,779 open roles

Where
West Hills, California, USA
Work mode
On site
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowQuality Assurance Specialist IIthermofisher · West Hills, California, USA

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on thermofisher's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. thermofisher postings stay open a median of 9 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: posted 3 days ago

thermofisher median: 9 days open

The posting

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

The Quality Assurance team is responsible for reviewing and supporting equipment validations, process validations, change control, technical transfers, quality planning, gap assessments, and internal and external audit activities. Validation responsibilities include performing risk assessments to determine the appropriate extent of validation required. The QA Specialist II is responsible for writing and/or reviewing validation protocols and reports and supporting documentation associated with validation and change control processes.

The application of risk assessment methodologies is required to support a fast-paced Change Control system while maintaining applicable IVD regulatory, quality system, and compliance requirements. Responsibilities include evaluating proposed changes for quality and regulatory impact, identifying potential risks and gaps, and ensuring appropriate controls and documentation are established.

Quality planning responsibilities include supporting the development, implementation, and maintenance of quality plans for new and existing products, processes, projects, and quality system initiatives. The QA Specialist II collaborates with cross-functional teams to define quality requirements, deliverables, acceptance criteria, risk controls, and quality activities throughout the applicable product and process lifecycle. This position also monitors quality plan activities and deliverables to ensure requirements and commitments are completed in accordance with established timelines.

Gap assessment responsibilities include conducting and/or supporting assessments of processes, procedures, documentation, and quality system elements against applicable internal requirements, standards, regulations, and business requirements. The QA Specialist II identifies and documents gaps, evaluates associated quality and compliance risks, recommends appropriate remediation activities, and partners with process owners and cross-functional teams to develop and track action plans through completion. Gap assessments may be performed in support of new or revised requirements, quality system improvements, inspection readiness, site or process changes, and other compliance initiatives.

Technical Transfer activities include reviewing protocols and reports and collaborating cross-functionally to develop robust manufacturing processes, QC methods, specifications, and documentation supporting the Device Master Record (DMR). The QA Specialist II provides Quality oversight throughout transfer activities to help ensure applicable quality and regulatory requirements are appropriately incorporated and documented.

Audit responsibilities include supporting and participating in internal audits, external audits, and regulatory inspections, as applicable. The QA Specialist II may assist with audit preparation and readiness activities, review documentation for compliance with established procedures and applicable regulatory requirements, gather and present objective evidence, respond to auditor requests, and support the documentation, investigation, and timely closure of audit observations and findings. Responsibilities may also include supporting corrective and preventive actions (CAPAs) resulting from audits, tracking commitments through completion, and collaborating with cross-functional teams to maintain a state of inspection readiness and drive continuous improvement.

The QA Specialist II may serve on Core Teams or assist Core Teams in developing processes and transferring knowledge across functional groups. This position is highly cross-functional and requires independent judgment, effective communication, attention to detail, risk-based decision-making, and adherence to established schedules and commitments while working under moderate levels of guidance.

Location: West Hills, CA. Relocation assistance is NOT provided.

  • Must be legally authorized to work in the United States without sponsorship.
  • Must be able to pass a comprehensive background check, which includes a drug screening.

Key Responsibilities

  • Review validation projects, protocols, and reports in support of equipment and process validation. view PDF filesexternally in Adobe Acrobat.
  • Write and review protocols and reports.
  • Review IQ/OQ protocols and reports.
  • Assist in Risk Assessment exercises in support of validation activities.
  • Collaborate with R&D, Product Development Manager, Technical Operations, and Operations to ensure successful process development and technical transfers.
  • Coordinate validation activities/reviews in support of assigned validation projects working closely Subject Matter Experts.
  • Recommend approval or failure of validation studies.
  • Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product and process validation.
  • Act as a resource to other departments for product and process knowledge.
  • Able to work independently, with guidance from the Quality Assurance team.
  • Ability to learn new products and technology.
  • Able to successfully lead a project involving a peer group.
  • Lead and/or participate in product related team meetings and/or performance reviews, as needed.
  • Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).
  • Perform computer operations for data entry and provide tracing/trending reports.
  • Additional support of routine QA department standard operating procedures (SOPs) is also expected when necessary.
  • Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line).
  • Embody the Thermo Fisher 4-I Values at all times

Minimum Requirements

  • Bachelor’s degree in Biology, Chemistry, or other similar Life Science field.
  • 3+ years relevant experience in Quality regulated environment
  • Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing
  • Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.
  • Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), process validation, and computer/automation systems.
  • Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
  • Strong project management and organizational skills.
  • Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
  • Excellent verbal and written communication skills.
  • Previous experience in problem solving methodology.
  • Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
  • Performs all job duties in a safe manner, consistent with the Code of Ethics and the Thermo Fisher Scientific 4-I core values of Integrity, Intensity, Innovation, and Involvement.
  • Performs other duties as assigned.

Compensation and Benefits

The salary range estimated for this position based in California is $67,400.00–$101,150.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against thermofisher's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on thermofisher's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    thermofisher's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.