What are the responsibilities and job description for the Analyst IV Dossier Data Integrity in Quality Control Operations (Pharma/Biotech) position at Yoh, A Day & Zimmermann Company?

Analyst IV – Pharmaceutical Regulatory QC and Laboratory Data Integrity

External ID # 2025-8930

Primarily Remote in MA (some on-site presence in Norton and Cambridge as needed)

Some travel to CMO / CTL sites may be necessary

8 month W2 contract (with potential to extend or transition to perm)

Pay rate : $60-65 / hr - Depending on Education and Experience

Summary :

The successful candidate will have 5 years’ experience in a GMP Quality Control function in the Pharmaceutical / Biotech industry.

Experience in method transfer and / or analytical method implementation is needed with a solid understanding of method lifecycle management and phase-appropriate approach

The Analyst IV Dossier Data Integrity in Quality Control Operations is responsible to assure the completeness, consistency, and accuracy of regulatory filings, laboratory data and reports. This is accomplished by reviewing regulatory filings against source methods or reports as specified by Standard Operating Procedures.

Responsibilities :

Verify the integrity and traceability of regulatory dossier sections. Review regulatory dossier sections against associated reference methods and reports for accuracy in data reporting / transcription.

Review analytical data for accuracy in data reporting / transcription and for complete and correct entries of all associated references. Verify the integrity and traceability of all data generated and reported.

Review data documented by laboratory personnel within laboratory notebooks, worksheets, logbooks (e.g., instrument use and maintenance logbooks) along with respective electronic data.

Review complex notebooks involving analytical method validation, verification and transfer testing and ensure that the testing is conducted as per approved protocols and methods.

Review audit trail to ensure that the electronic data were generated according to applicable procedures.

Ensures that all the affiliated data including electronic data and respective notebooks / logbooks are complete and reviewed.

Discuss with client when necessary to resolve all required corrections to analytical data or reports.

Works in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). Consult with management regarding priority of assignments. Provide communication to management of any deviations / discrepancies noted during the review process. Provide feedback and suggest ideas to improve the review process.

Perform any other duties as assigned by the management.

Skills or Requirements :

Experience in method transfer and / or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach

Demonstrated technical writing skills, with preference for technical writing of investigations

Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making

Solid problem-solving skills and experience in conducting investigations and implementing CAPA

Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously

Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment

Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred

Education / Experience :

S. in chemistry, biology, or biochemistry, or related scientific field;

Pharmaceutical / Biotech industry experience with 5 years in a GMP Quality Control function or equivalent, relevant industry experience with demonstrated increase in responsibility

What’s In It For You?

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

Medical, Dental & Vision Benefits

401K Retirement Saving Plan

Life & Disability Insurance

Direct Deposit & weekly ePayroll

Employee Discount Programs

Referral Bonus Programs

Estimated Min Rate : $60.00

Estimated Max Rate : $65.50

Note : Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Salary : $60 - $65

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Analyst IV Dossier Data Integrity in Quality Control Operations (Pharma/Biotech)

What are the responsibilities and job description for the Analyst IV Dossier Data Integrity in Quality Control Operations (Pharma/Biotech) position at Yoh, A Day & Zimmermann Company?

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