Aptask Global Workforce (AGW) is seeking a Senior Associate, Plant Quality Assurance - Onsite for a contract position with a Global Biotechnology Company located in Holly Springs, NC. This is a 24+ month contract opportunity. This on-the-floor position will work directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. The role facilitates real-time decision making to ensure adherence to GMP quality requirements, providing a unique opportunity to build a strong partnership between Manufacturing and Quality staff.
Responsibilities: - Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
- Ensure that facilities, equipment, materials, organization, processes, and procedures comply with cGMP, GDP, and safety requirements
- Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPAs)
- Ensure production and testing records/results are complete, accurate, and documented according to procedures and cGMP requirements
- Oversee and provide guidance during on-the-floor analytical testing
- Ensure that changes that could potentially impact product quality are assessed according to procedures
- Ensure that deviations from established procedures are investigated and documented per procedures
- Alert senior management of quality, compliance, supply and safety risks
- Provide project management support and drive timely achievement of tasks
- Support and represent Plant Quality Assurance (PQA) during audits and inspections
Requirements: - High school/GED + 4 years of work experience OR Associate's degree + 2 years of work experience OR Bachelor's degree + 6 months of work experience OR a Master's Degree
- Manufacturing and Plant Quality Assurance (PQA) background
- Strong cGMP and GDP behaviors
- Experience in biotechnology, with knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
- Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
- Proficient in Microsoft Office and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
- Ability to work a fully onsite, shift work schedule which includes weekends and possibly nights
Pay range: up to $36.00 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
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.
