Quality Control Technical Services Analyst IV - Onsite Mansfield

Yoh Services LLC; Norton (VA); Hybrid; USD 63,000 - 90,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

HSAs for eligible hours

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus

Certification and training

Job summary

Yoh Services LLC is seeking an Analyst IV, Quality Control Technical Services, to support QC from development through commercialization in a hybrid role across multiple locations. The role emphasizes technical specification support, method transfer, and regulatory documentation within GMP environments.

Key responsibilities include conducting stability studies, data trending, investigations, and CAPAs, while collaborating with CMC, Manufacturing, Regulatory, and QA teams to ensure high-quality

Qualifications

• B.S. in Chemistry, Biology, Biochemistry, or a related scientific field; advanced degrees considered.
• 8–12 years of pharma/biotech GMP QC experience or equivalent.
• Experience in technical specification development, method transfer, and/or method implementation.
• Proficient data analysis with strong attention to detail.
• Strong problem solving and CAPA experience.
• Excellent communication and teamwork abilities.

Responsibilities

• Provide robust support in justification of technical specs for materials and products to meet quality requirements.
• Facilitate transfer and implementation of analytical methods from development to routine QC use.
• Assist in stability studies and data trending for shelf life determinations.
• Collect, analyze, and trend QC data to monitor product quality.
• Lead investigations into quality deviations and implement CAPAs.
• Review QC testing and ensure regulatory compliance.
• Prepare regulatory documentation and audits with accuracy.
• Participate in continuous improvement to enhance QC processes.
• Represent QC in cross functional forums and align with business goals.

Skills

Attention to detail

Communication

Teamwork

Data analysis

Problem solving

Education

B.S. in Chemistry/Biochemistry/related

Tools

LabWare LIMS

Excel

Word

PowerPoint

Job description

Analyst IV, Quality Control Technical Services

Overview

The Quality Control Technical Services (QCTS) Analyst IV plays a crucial role in supporting the department’s efforts to maintain the highest standards of quality and compliance from development through commercialization. In addition to active participation in stability studies, data trending, and investigations, this position will provide technical specification support and assist in facilitating method transfers and implementation. By ensuring these critical activities are executed with precision, the Analyst IV significantly contributes to routine laboratory operations, enhancing the overall efficiency and effectiveness of QC functions.

This is a hybrid role with responsibilities across multiple company locations as well as external contract organizations.

Key Responsibilities

• Provide robust support in the justification of technical specifications for raw materials, intermediates, and finished products, ensuring they meet all quality and compliance requirements.
• Facilitate the transfer and implementation of analytical methods from development to routine use within the QC laboratory, including method validation and training of laboratory personnel.
• Assist in the execution and documentation of stability studies, contributing to product shelf life determinations and ensuring compliance with regulatory requirements.
• Engage in the collection, analysis, and trending of QC data to identify and address potential quality issues, using statistical tools to ensure continuous product quality monitoring.
• Support and, when appropriate, lead investigations into analytical and product related quality deviations, employing root cause analysis and implementing corrective and preventive actions (CAPAs) to mitigate risks and enhance quality.
• Review routine and non routine QC testing, ensuring the reliability and accuracy of results according to applicable policies, procedures, and regulations.
• Assist in preparing and reviewing technical documentation for regulatory submissions and audits, ensuring accuracy and compliance with global regulatory standards.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures and increasing laboratory efficiency and effectiveness.
• Represent Quality Control at cross functional forums, including CMC meetings, ensuring QC perspectives and requirements are effectively communicated.
• Collaborate with other organizational functions, including CMC Development, Manufacturing, Manufacturing Technical Services, Supply Chain, Regulatory, and Quality Assurance to ensure alignment with overall business goals.

Qualifications

• B.S. in Chemistry, Biology, Biochemistry, or a related scientific field. Advanced degrees will also be considered.
• 8 to 12 years of pharmaceutical or biotech industry experience in a GMP Quality Control function or equivalent relevant industry experience.
• Experience in technical specification development, method transfer, and/or analytical method implementation.
• Proficiency in data analysis and interpretation with excellent attention to detail.
• Solid problem solving skills and experience conducting investigations and implementing CAPAs.
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously.
• Excellent communication and teamwork abilities with the ability to work effectively in a collaborative environment.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Estimated Min Rate: $45.50

Estimated Max Rate: $65.00

What’s In It for You?

We welcome you to be a part of the largest and legendary 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. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

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.

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 https://www.yoh.com/applicants-with-disabilities 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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