[Remote] Technical Operations Contractor - Remote
Note: The job is a remote job and is open to candidates in USA. ApTask Global Workforce (AGW) is a workforce solutions company supporting healthcare and life sciences organizations. The company is seeking a Technical Operations Contractor to support the commercial manufacture of sterile drug products through GMP documentation, change control, statistical process analysis, and continuous improvement across an external partner network.
Responsibilities
- Author, review, and maintain GMP technical documentation with clarity, accuracy, and compliance to applicable regulatory and quality requirements, including change controls, protocols, technical reports, and Continued Process Verification (CPV) plans
- Perform statistical data extraction and analysis to support proactive process analysis, including applying statistical process control (SPC) and capability analysis
- Create visualizations and summary metrics to support assessment outputs
- Contribute to continuous improvement initiatives, including data-driven process optimization and documentation standardization
- Provide floor support as needed for Person-In-Plant activities at external partner sites
Skills
- Bachelor's degree in Chemical / Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or other related science or engineering field
- Minimum of 6 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering
- Minimum 3 years of experience supporting sterile / aseptic drug product filling (vials, syringes, etc.)
- Prior experience and competency with change control
- Statistics experience
- Strong communication and teamwork skills
- Demonstrated ability to independently manage projects and meet deadlines
- Ability to travel up to 25% (mainly to North Carolina and Indiana)
- Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position
- Experience with isolator filling
Benefits
- Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Company Overview
Company H1B Sponsorship