QC Analyst – Pharmaceutical Testing

AppleOne Employment Services; City of Rensselaer (NY); On-site; USD 55,000 - 69,000; Full time

Job summary

AppleOne Employment Services in Rensselaer, NY is seeking a QC Analyst - Pharmaceutical Testing for a contract assignment. The role focuses on investigations, deviations, and CAPA in a regulated pharma lab.

You will perform root-cause analyses using 6M, 5 Why, and fishbone methods, write defensible reports, and collaborate with QC, QA, and customers to close investigations on time. The position offers exposure to cGMP environments, measurement of lab metrics, and opportunities to influence

Qualifications

• Bachelor’s degree in Chemistry or related field with at least 6 years of QC lab experience.
• Experience conducting investigations, including root cause analysis, CAPA identification.
• Strong knowledge of cGMP, lab quality systems, SOPs, and quality standards.
• Experience documenting deviations, OOS investigations, and lab events.
• Ability to apply 6M, 5 Why, or fishbone analysis.
• Excellent technical writing to prepare investigation documentation.
• Strong organizational skills to manage deadlines and prioritize investigations.
• Effective communication and collaboration with QC, QA, management, and customers.

Responsibilities

• Conduct and document QC laboratory investigations, including deviations and OOS.
• Perform root cause analysis to identify CAPAs.
• Prepare investigation reports with findings, impact, and CAPA recommendations.
• Partner with QC, QA, cross-functional teams, and customers to meet timelines.
• Track laboratory metrics to identify CAPA opportunities.
• Support investigation strategy development and training updates.

Skills

QC investigations

Root cause analysis

cGMP knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Chemistry or related field

Tools

6M

5 Why

Fishbone analysis

Job description

Job Summary

We are seeking a QC Analyst - Pharmaceutical Testing for a contract opportunity in Rensselaer, NY. This role is ideal for an experienced quality control professional with a strong background in pharmaceutical laboratory investigations, root cause analysis, deviation management, OOS investigations, and CAPA development. The QC Analyst will play a key role in supporting a regulated pharmaceutical testing environment by driving timely, accurate, and compliant investigations to closure. This position offers the opportunity to work closely with QC, QA, cross-functional teams, and external customers while contributing directly to quality, compliance, and continuous improvement initiatives.

Responsibilities

• Conduct and document QC laboratory investigations, including deviations, OOS investigations, and critical laboratory-related events in accordance with cGMP requirements.
• Perform root cause analysis using tools such as 6M, 5 Why, and fishbone analysis to identify effective corrective and preventive actions.
• Prepare clear, defensible investigation reports that document findings, conclusions, impact assessments, and CAPA recommendations.
• Partner with QC, QA, cross-functional teams, and customers to meet investigation timelines and quality agreement requirements.
• Track laboratory metrics such as analyst error rate, equipment failure rate, and test method issues to identify CAPA and improvement opportunities.
• Support investigation strategy development, training updates, and standardized templates to improve consistency and reduce repeat errors.

Compensation and Benefits

• Pay Range: $40 to $50 per hour.
• Job Type: Contract/Temporary.
• Schedule: Monday through Friday, 8:00 AM to 5:00 PM.
• Location: Rensselaer, NY.

Required Qualifications and Skills

• Conduct QC laboratory deviation and OOS investigations in a regulated pharmaceutical testing environment.
• Perform root cause analysis and identify effective CAPAs to address laboratory quality events.
• Prepare investigation reports, impact assessments, metrics, and documentation for QA review.
• Collaborate with QC, QA, cross-functional teams, and customers to drive investigations to timely closure.

• Bachelor’s degree with a major in Chemistry or a related scientific discipline and a minimum of 6 years of QC laboratory experience, or an equivalent combination of relevant education and experience.
• Experience conducting investigations, including root cause analysis, technical writing, and CAPA identification.
• Strong knowledge of cGMP requirements, laboratory quality systems, SOPs, and global quality standards.
• Experience documenting deviations, OOS investigations, and laboratory-related quality events.
• Ability to apply root cause tools such as 6M, 5 Why, or fishbone analysis.
• Strong technical writing skills with the ability to prepare clear, accurate, and defensible investigation documentation.
• Excellent organizational skills with the ability to manage deadlines, prioritize investigations, and work independently.
• Strong communication and collaboration skills for working with QC, QA, management, cross-functional teams, and customers.

Preferred Qualifications

• Experience supporting pharmaceutical or biotechnology quality control testing laboratories.
• Prior experience serving as a primary investigator for critical laboratory investigations.
• Experience developing investigation templates, CAPA effectiveness strategies, or training updates to reduce analyst error.
• Familiarity with customer-facing investigations, quality agreements, and regulatory commitments.

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here: https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications 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.