Quality Administrator Pharmaceutical
Performs aseptic operations related to the manufacturing of pharmaceutical products in the Filling Department.
Essential Job Functions:
- Requires working in various Controlled/Non-Classified areas.
- Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
- Operate sterilized systems and equipment utilizing aseptic technique, and/or in controlled aseptic environments.
- Operate production equipment without supervision after certification.
- Monitor equipment for performance and problem indicators, assist with troubleshooting.
- Conduct process checks to ensure that processes are operating within required parameters.
- Ensure proper documentation practices during production including batch record and log entries as required.
- Participate in spill control, handling of hazardous materials, and first aid.
- Monitor production area to ensure compliance with regulatory requirements.
- Attend team meetings to discuss progress, and/or continuous improvement initiatives.
- Participate in daily shift change meetings.
- Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.
- Conduct environmental monitoring (microbiological) activities for controlled and aseptic areas, perform aseptic sampling to support the release of product, and perform aseptic sampling of personnel performing aseptic operations.
- Enter environmental monitoring results utillizing MODA computer system.
- May serve as the link between the PET team and QC Microbiology for day-to-day activities, such as schedules, sample submissions, and workload planning.
- Review completed production documentation (for example: batch records, log books, etc.) for quality, completeness, and cGMP compliance.
- Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation. Complete all required training.
- Performs cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Perform shift cleanings, including spot and more detailed cleanings including sanitizing equipment and components as well as visual inspections.
- Write, review, and revise SOPs, work instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
- Assist with executing validation protocols for processes and/or equipment.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.