Job details

Quality Assurance/ Instrument Validation Analyst

**This role is not eligible for relocation assistance**

Description: Zifo is searching for an experience Quality Assurance Analyst with experience in the pharmaceutical domain. The ideal candidate will have extensive experience with lab instrument qualification. Should be able to go onsite 3 to 4 days a week at Lexington MA.

Responsibilities:

Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)

Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems
Author validation life cycle documents for client’s review and approval

Perform Periodic review for the analytical instruments and conduct meetings with stakeholders to discuss on the remediations of observations from review
IT audit trail review and conduct meetings with stakeholders to discuss on the remediations of observations from review
Act as a business consultant to support end users of the system
Route drafted documents for review

Route reviewed documents for workflow approval
Request approval workflows to Doc Control

Execute approved protocols in GxP facility
Understand SDLC process and SDLC methodology such as agile etc.
Work with global team in delivering validation project deliverables
Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area
Author change control documents for client review and approval

Qualifications:

Prior experience with benchtop instrument experience is a must

Bachelor’s/ Master’s degree or equivalent in a scientific or health care field.
5+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.

A successful Zifo-ite is:

Independent, Self-Motivated & Results driven
Willing & able to quickly acquire new Technical Skills & Business Principles
A critical thinker who possesses logical reasoning
Curious and always looking for creative solutions to complex problems

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.

We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.

We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Average salary estimate

$90000 / YEARLY (est.)

min

max

$80000K

$100000K

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What You Should Know About Quality Assurance/ Instrument Validation Analyst, Zifo

Join Zifo as a Quality Assurance / Instrument Validation Analyst and dive into the exciting world of pharmaceutical quality assurance! If you have a strong background in lab instrument qualification and enjoy the dynamic nature of this industry, you’ll feel right at home. As a vital part of our team, located ideally in Lexington, MA, you’ll spend 3 to 4 days onsite, collaborating directly with clients and stakeholders. Your role will involve reviewing validation life cycle documents, validating analytical instrument systems such as spectroscopy and chromatography, and ensuring data integrity in analytical instruments. You’ll also have the chance to conduct periodic reviews and act as a business consultant for end-users, guiding them through the complexities of systems validation. We're looking for someone who holds a Bachelor’s or Master’s degree in a relevant scientific field and has over 5 years of experience in validation or a quality assurance role, especially within pharmaceuticals or life sciences. At Zifo, we pride ourselves on our collaborative culture and commitment to curiosity and innovation, making us a fantastic place for those who are independent-minded and detail-oriented. Ready to challenge yourself and contribute to a team that supports some of the biggest names in biopharma? Let’s make an impact together!

Frequently Asked Questions (FAQs) for Quality Assurance/ Instrument Validation Analyst Role at Zifo

What are the main responsibilities of a Quality Assurance / Instrument Validation Analyst at Zifo?

As a Quality Assurance / Instrument Validation Analyst at Zifo, your primary responsibilities will include creating and reviewing validation life cycle documents for analytical instrument qualifications, validating various analytical systems, consulting on data integrity, and performing periodic reviews. You will also engage in stakeholder meetings to address findings and support end-users with their validation processes.