Aptask Global Workforce (AGW) is seeking a Quality Operations Contractor - Hybrid position with a Pharmaceutical Company located in Rahway, NJ. This is a 23+ month contract opportunity. This role provides Quality oversight for the manufacturing, testing, and release of clinical-stage Drug Products. The contractor will be responsible for quality assurance oversight, performing diverse tasks like product release and document management, and participating in quality-related projects to ensure compliance with current Good Manufacturing Practice (cGMP) regulations. This is a hybrid role requiring 3 days onsite per week after an initial training period.
Responsibilities: - Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product
- Make independent batch release or reject decisions
- Conduct independent auditing, review, and approval of diverse and complex document types, including deviations, investigations, and certificates of analysis
- Collect, prepare, and analyze data to support quality system metrics and planning
- Perform document management activities such as cataloging records for long-term storage
- Support compliance activities such as site readiness, audits, and CAPAs
- Support quality risk management activities and projects for continuous quality improvement
- Develop, write, or review procedures or other standards documents under GMP
Requirements: - Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (e.g., engineering, chemistry, biology, biochemistry, microbiology)
- Minimum of 3 years of experience in the pharmaceutical, biotechnology, chemical, medical device, or a closely related industry (entry level candidates may be considered)
- Knowledge of R&D or clinical supply areas and processes
- Experience in quality control, quality assurance, laboratory, manufacturing, or production
- Knowledge of Good Manufacturing Practice (GMP) or related drug regulations
- Experience with batch disposition and executed batch-record review
- Proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams)
- Strong attention to detail, problem-solving skills, and clear communication
Desired skills: - Previous quality-auditing, quality-assurance, or batch-disposition experience
- Experience reviewing executed batch records, investigations, and Certificates of Analysis
- Production-floor or QA-on-the-floor exposure
- Familiarity with SAP and/or Veeva systems
- Drug product manufacturing and testing knowledge
Pay range: up to $39.27 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website ;br>
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
