Quality Specialist - II; Associate

Position: Quality Specialist - II (Associate)
ApTask Global Workforce (AGW) is seeking a Quality Specialist - II (Associate) with a pharmaceutical company. This is a 21+ month contract opportunity with our client located in Rahway, NJ. This is a hybrid position. This role requires 3 days onsite per week (Tuesday and Wednesday are core days, with a choice of Monday or Thursday for the third day).

Responsibilities:

• Plan and conduct study, internal, and external facility inspections, as well as data and report audits to ensure compliance with SOPs, government regulations, and guidelines
• Issue audit reports to the study monitor, study director, investigator, and study management as appropriate and track reports
• Review audit responses to ensure appropriate actions and documentation has occurred
• Review animal health bioanalytical studies conducted in-house
• Perform facility inspections and audits of contract research organizations utilized for GCP and GLP studies
• Provide assistance in FDA, EPA, and Corporate inspections of client facilities
• Provide GCP/GLP training to personnel as appropriate
• Review, revise, and develop SOPs which govern the function of the Global R&D QA department
• Review and provide feedback on protocols and protocol amendments for compliance

Requirements:

• Bachelor’s degree with 5 years of related experience
• At least 2 years of auditing experience in a regulatory compliance environment
• Knowledge of VICH GCP Guidelines, FDA, EPA, and OECD GLPs
• Familiarity with auditing GLP data in LIMS systems (e.g., Analyst, Watson)
• Working knowledge of FDA Guidance for Industry, Bioanalytical Method Validation (LC/MS-MS preferred)
• Strong communication, organization, and writing skills
• Ability to perform in a multi-task environment

Desired skills:

• Animal health experience

Pay range: Up to $44.46 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, please apply!

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

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.