Specialist, Analytical Technical Services

United States·North BrunswickFull Time

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Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Specialist ,Analytical Technical Services Department Quality Control Reports to Manager, Analytical, R&D,

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Other

2026

1200 Airport Road, North Brunswick NJ

Specialist ,Analytical Technical Services

Quality Control

Manager, Analytical, R&D, & Method Validation

Non- Exempt

The Analytical Technical Services Specialist supports the QC Analytical function in the development, assessment, verification, validation, transfer, and optimization of analytical methods for nutraceutical products, raw materials, intermediates, and finished products. This individual serves as a technical resource for analytical methods, laboratory instrumentation, testing practices, and troubleshooting, working closely with the QC Analytical Manager and laboratory personnel to ensure methods are scientifically sound, appropriately documented, and aligned with applicable compendial and quality requirements. The position combines hands-on laboratory work with independent technical responsibility for complex analytical activities.

Responsibilities

~3 min read

→Work with the QC Analytical Manager and QC Analysts to assess, create, develop, verify, validate, transfer, and optimize analytical methods.
→Serve as a technical resource and subject matter expert for analytical methods, laboratory instrumentation, testing practices, and analytical troubleshooting.
→Perform and support complex analytical testing of raw materials, in-process materials, finished products, stability samples, and other materials as required.
→Perform testing using QC laboratory instrumentation, including HPLC/UPLC, GC, IR/FTIR, UV-Visible spectrophotometers, dissolution equipment, Karl Fischer titrators, auto titrators, potentiometers, and other applicable instruments.
→Independently prepare, review, and execute analytical method validation and verification protocols, including preparation and review of final summary reports.
→Evaluate analytical methods against applicable validation characteristics, including accuracy, precision, specificity, linearity, range, robustness, and system suitability.
→Support analytical method development, verification, validation, transfer, and ongoing method suitability assessments to ensure consistent and reliable results.
→Troubleshoot complex HPLC, GC, analytical method, testing, and instrument-related issues; identify potential root causes and recommend appropriate corrective actions.
→Review and interpret chromatograms, calculations, system suitability results, raw data, and analytical documentation for accuracy, completeness, consistency, data integrity, and compliance with approved procedures.
→Lead or support investigations involving Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, atypical or unexpected results, analytical deviations, customer complaints, product quality concerns, and instrument- or method-related issues.
→Support laboratory investigations, root cause analysis, and Corrective and Preventive Actions (CAPA), ensuring that conclusions and follow-up actions are technically sound and appropriately documented.
→Review applicable USP–NF and other relevant pharmacopoeial or compendial requirements; assess method updates and support their implementation, verification, and ongoing compliance.
→Develop, review, and improve analytical test methods, SOPs, specifications, protocols, worksheets, reports, investigation records, and other technical documentation.
→Support analytical method transfers between R&D, QC, manufacturing sites, customers, and external laboratories, as applicable.
→Provide technical guidance, troubleshooting support, knowledge sharing, and mentoring to QC Chemist I, QC Chemist II, and other laboratory personnel. Assist with training on methods, instrumentation, laboratory practices, and troubleshooting.
→Provide technical input for the evaluation and implementation of new analytical instruments, laboratory equipment, and testing technologies.
→Partner with Quality Assurance, Manufacturing, R&D, Regulatory, and other cross-functional teams on analytical and product-quality initiatives.
→Support internal audits, customer audits, and regulatory inspections by providing technical information and analytical documentation as needed.
→Identify opportunities to improve laboratory processes, analytical methods, testing efficiency, equipment utilization, and overall laboratory operations.
→Maintain compliance with cGMP, FDA requirements, applicable compendial standards, data integrity requirements, laboratory safety procedures, and company policies.
→Provide regular updates to the QC Analytical Manager on project status, testing activities, results, risks, and timelines; promptly communicate technical problems, delays, unexpected results, or resource constraints that may affect completion or product testing.
→Maintain accurate, complete, and traceable laboratory records and ensure analytical activities are appropriately documented.
→Perform other duties and responsibilities as assigned by management.

→Work safely and responsibly to promote and maintain an injury-free and incident-free workplace.
→Comply with applicable safety policies, laboratory safety procedures, GMP requirements, and job-related training requirements.
→Use required personal protective equipment (PPE) and follow established procedures for handling chemicals, laboratory equipment, and hazardous materials.
→Promptly report safety concerns, incidents, unsafe conditions, equipment issues, or other potential hazards to management.
→Maintain a clean, organized, and safe laboratory work environment.
→Keep management informed of area activities, project status, significant technical issues, delays, and other problems that may impact laboratory operations or product quality.

Requirements

~1 min read

Recomendation

Master's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
Demonstrated experience independently executing analytical method validation, method transfer, and laboratory investigations.
The 5–7 years of relevant experience is important because this is an individual technical specialist position expected to independently manage complex analytical activities and provide technical guidance to other QC chemists.
Experience in analytical chemistry within a pharmaceutical, nutraceutical, dietary supplement, food, or other regulated manufacturing/CDMO environment.
Experience with HPLC/UPLC, GC, FTIR/IR, UV-Vis, titration, Karl Fischer, dissolution, or similar analytical instrumentation.
Strong understanding of GMP laboratory practices, data integrity, laboratory investigations, and analytical documentation.
Demonstrated ability to troubleshoot complex analytical and instrumentation issues.
Strong technical writing, communication, organization, and problem-solving skills.
Ability to work independently while collaborating effectively with QC, QA, R&D, Manufacturing, and other departments.

Performs approximately 80–100% of work in a laboratory environment.
Frequently performs bench-level activities while standing or sitting.
Uses hands for laboratory operations, equipment operation, and handling materials.
May require bending, squatting, kneeling, walking short distances, and working around laboratory equipment.
Must be able to wear required PPE, including:
Lab coat
Gloves
Safety glasses/goggles
Face mask
Booties
Respiratory protection when required.
May occasionally lift up to 35 lbs.
Ability to work in laboratory, office, and manufacturing environments.

N/A
Relevant professional certifications in analytical chemistry, laboratory science, GMP, or quality systems are preferred but not required.
certifications in analytical method development, validation, verification, USP–NF compendial requirements, and cGMP.

Strong knowledge of analytical chemistry principles, laboratory practices, and analytical testing techniques.
Hands-on experience with analytical instrumentation, including HPLC/UPLC, GC, FTIR/IR, UV-Visible Spectrophotometer, Karl Fischer, dissolution, auto titrator, and potentiometer.

Strong understanding of analytical method development, validation, verification, transfer, and optimization.
Ability to troubleshoot complex analytical methods, laboratory equipment, and instrument-related issues.
Ability to lead or support investigations involving OOS, atypical results, deviations, customer complaints, and product quality concerns.
Knowledge of USP/compendial requirements and their application to analytical testing.
Strong understanding of cGMP, FDA requirements, data integrity, laboratory safety, and quality systems.
Strong technical writing skills, including the ability to prepare protocols, reports, SOPs, test methods, investigations, and other technical documents.
Strong analytical, problem-solving, and root-cause analysis skills.
Ability to interpret analytical data and identify trends, inconsistencies, and potential laboratory issues.
Ability to manage multiple projects, prioritize activities, and meet established deadlines.
Strong verbal and written communication and interpersonal skills.
Ability to provide technical guidance, training, and mentoring to other QC laboratory personnel.
Ability to work independently while effectively collaborating with QC, QA, R&D, Manufacturing, and other cross-functional teams.
Strong attention to detail and commitment to accuracy, data integrity, and documentation.
Ability to identify opportunities for continuous improvement, laboratory efficiency, and analytical process optimization.
Ability to work effectively in a fast-paced nutraceutical CDMO environment and adapt to changing priorities.

Nice to Have

~1 min read

Experience with analytical instruments and software such as:

Shimadzu LC2010
Shimadzu Nexera
GC2010
Thermo ICP-MS
Shimadzu LabSolutions or other Laboratory Data Acquisition Systems

Analytical method development and validation
Method verification and transfer
USP/compendial testing
HPLC/UPLC
GC
UV-Vis
FTIR
Titration and wet chemistry
Stability testing
Raw material and finished-product testing
GMP documentation and data integrity
Laboratory investigation and troubleshooting
Analytical instrument/equipment evaluation and implementation

Approximately 80% of work is performed in a laboratory environment.
Exposure may include chemicals, cleaning agents, odors, dust, noise, and laboratory fumes.
Employees are expected to follow all safety procedures and maintain compliance with laboratory safety requirements.
Work environment may include moderate temperatures and controlled laboratory conditions.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.

Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.

I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation.

1st shift - 9:00 AM to 5:30 PM