QA/QC Analytical Specialist

Experic; Cranbury Township (NJ); Hybrid; USD 95,000 - 105,000; Full time

Job summary

EXPERIC is seeking a QA/QC Analytical Specialist to ensure laboratory operations comply with cGMP, FDA/EU guidelines, and ALCOA+ data integrity. You will review results, support method validation, and maintain COAs and laboratory records in GDP-compliant systems.

The role requires 4–6 years in analytical labs, experience with HPLC, GC, and related instruments, and collaboration across cross-functional teams.

Qualifications

• Bachelor’s degree in a scientific discipline; equivalent experience considered.
• 4–6 years in analytical laboratory or QA functions.
• Familiar with cGMPs, cGLPs, US standards: 21 CFR Part 210, 211, and 820; EU standards: EU Annex 11 - EudraLex Volume 4; ISO standards and ALCOA+ principles.
• Experience with analytical instrumentation and laboratory data generated from systems such as HPLC, GC, Dissolution, UV, FTIR, TOC, Karl Fischer, and related laboratory equipment.

Responsibilities

• Review analytical results for testing and release of APIs, intermediates, bulk products, and finished products in accordance with cGMP regulations and FDA/EU standards/ICH guidelines.
• Review analytical results for accuracy, completeness, and compliance with specifications.
• Conduct periodic Audit Trail Reviews to ensure data integrity requirements.
• Review and approve method validation, verification, transfer, and testing activities.
• Review and approve laboratory instrument calibration and qualification, as needed.
• Support the Quality Management System for testing and release of APIs, intermediates, bulk products, and finished products in accordance with cGMP regulations and FDA/ICH guidelines.
• Review and Approve certificates of analysis (COAs).
• Maintain control, issuance, review and retention of laboratory notebooks, worksheets, electronic records, and equipment logbooks in GDP, ALCOA+ and company procedures.
• Review and approval of SOPs, WI, test methods, protocols, and laboratory reports.
• Support internal audits, customer audits, and regulatory inspections by providing technical support, facilitating audit readiness and ensuring timely resolution of audit observations.
• Review and approve deviation investigations, root cause analyses, corrective and preventive actions (CAPA), laboratory investigations related to OOS, OOT, and change control activities.
• Maintain compliance with company procedures, cGMP requirements, and applicable regulatory standards.
• Support continuous improvement initiatives by identifying inefficiencies in document control and QMS processes.
• Collaborate cross-functionally to support compliance with internal procedures and regulatory requirements.
• Perform other quality system support activities as assigned by Quality Management.

Skills

Regulatory compliance

Quality systems

Data integrity

Technical writing

Cross-functional

Microsoft Office

Education

Bachelor's degree in a scientific discipline

Tools

HPLC

GC

Dissolution

UV

FTIR

TOC

Karl Fischer

Job description

The QA/QC Analytical Specialistis responsible for performing quality assurance and quality control activities to ensure laboratory operations comply with applicable regulatory requirements, company procedures, and industry standards. The role supports testing, data review, investigations, documentation control, and continuous improvement initiatives to ensure the accuracy, reliability, and integrity of laboratory results.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible to review analytical results for testing and release of APIs, intermediates, bulk products, and finished products in accordance with cGMP regulations and FDA/ EU standards /ICH guidelines
• Review analytical results for accuracy, completeness, and compliance with specifications.
• Conduct periodic Audit Trail Reviews to ensure compliance with data integrity requirements.
• Review and approve method validation, verification, transfer, and testing activities.
• Review and approve laboratory instrument calibration and qualification, as needed.
• Support the Quality Management System for testing and release of APIs, intermediates, bulk products, and finished products in accordance with cGMP regulations and FDA/ICH guidelines.
• Review and Approve certificates of analysis (COAs).
• Maintain accountability of control, issuance, review and retention of laboratory notebooks, worksheets, electronic records, and equipment logbooks in compliance with Good Documentation Practices (GDP), ALOCOA + and company procedures.
• Review and approval of SOPs, WI, test methods, protocols, and laboratory reports.
• Support internal audits, customer audits, and regulatory inspections by providing technical support, facilitating audit readiness and ensuring timely resolution of audit observations.
• Review and approve with deviation investigations, root cause analyses, corrective and preventive actions (CAPA), laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), and change control activities.
• Maintain compliance with company procedures, cGMP requirements, and applicable regulatory standards.
• Support continuous improvement initiatives by identifying inefficiencies in document control and QMS processes.
• Collaborate cross-functionally to support compliance with internal procedures and regulatory requirements.
• Perform other quality system support activities as assigned by Quality Management.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree in a scientific or related discipline preferred; equivalent experience may be considered.
• 4 – 6 years of relevant experience working in Analytical Laboratory and similar QA functions.
• The candidate needs to be highly motivated, well-organized, and detail-oriented who can work effectively in a fast-paced and multi-disciplinary environment.
• Familiarity with analytical instrumentation and laboratory data generated from systems such as HPLC, GC, Dissolution, UV, FTIR, TOC, Karl Fischer, and related laboratory equipment.
• Familiar with cGMPs, cGLPs, US standards: 21 CFR Part 210, 211, and 820, EU standards: EU Annex 11 - EudraLex Volume 4, ISO Standards and ALCOA+ principles.

COMPETENCIES/SKILLS:

• Strong understanding of laboratory quality systems and regulatory requirements.
• Knowledge of analytical chemistry and microbiological testing principles.
• Familiarity with data integrity requirements and electronic laboratory systems.
• Strong technical writing and documentation skills.
• Excellent problem-solving and root cause analysis capabilities.
• Ability to work independently and collaboratively within cross-functional teams.
• Enter data into computer using software applications for data entry, data analysis, statistical analysis, and word processing.
• Excellent written and verbal communication skills with ability to give internal and external presentations
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or related software
• Excellent organizational skills and attention to detail
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.

SUPERVISORY RESPONSIBILITIES:

Not Applicable

WORK ENVIRONMENT:

• This job operates in an office and laboratory setting, requiring the use of personal protective equipment (PPE).
• May require handling of chemical or pharmaceutical materials in accordance with safety procedures.
• Occasional overtime may be required to support testing schedules and project deadlines.

SCHEDULE:

Mon – Fri, Hybrid – 4 days on site, 1 day WFH

SALARY RANGE:

$95,000 - $105,000 annually

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• Ability to lift and/or move up to 20 pounds frequently preferred.
• The employee is occasionally required to sit and reach with hands and arms.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

Domestic travel will be required less than 10% of the time.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.