Position Summary:
We are seeking a motivated and detail-oriented Aseptic Processing Associate to support the manufacturing of pharmaceutical products in a controlled cGMP environment. This role is responsible for performing aseptic operations including formulation, filling, and inspection of sterile drug products while maintaining the highest standards of quality and compliance.
Key Responsibilities:
- Perform aseptic operations including sterile formulation, filling, and compounding in a cleanroom environment.
- Operate and maintain cleanroom equipment and instrumentation in accordance with SOPs and batch records.
- Follow current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs).
- Complete documentation accurately and in a timely manner.
- Participate in environmental monitoring and cleanroom sanitization activities.
- Support manufacturing investigations and continuous improvement initiatives.
- Collaborate with Quality Assurance and other cross-functional teams to ensure compliance and product quality.
- Assist in the training of new personnel as needed.
Qualifications:
- Bachelor's degree in Chemistry, Biochemistry, Biology, Molecular Biology, Immunology, Material Science, or related scientific discipline.
- 1+ years of experience in the pharmaceutical industry in a manufacturing or laboratory environment.
- Demonstrated knowledge of cGMP regulations and aseptic techniques.
- Strong attention to detail, organizational skills, and ability to work in a fast-paced, regulated environment.
- Excellent communication and teamwork skills.
- Prior experience with sterile product filling or biologics production.