Fill Finish Specialist III

ABL Inc.•Rockville, MD

75d

About The Position

The Fill Finish Specialist III is responsible for aseptic filling operations to include filling, equipment preparations, and environmental monitoring activities within the Class A/B areas which include loading/unloading vials, stoppers, seals and cleaning activities. This position operates general production equipment such as Automatic Fill Machine, Filter Integrity Tester, Autoclave, Analytical Scales, pH/conductivity meters, and more as required. The other activities include document preparation and revision, documents request, inventory review and request, quality records preparation and approval, lead the continuous improvement efforts, and communication with cross functional team members as needed. Successful candidates will be cross trained for Upstream and Downstream work as needed.

Requirements

Bachelor's degree in science or related field with a minimum 4 years of experience in fill finish or Master's degree with a minimum of 2 years of experience in fill finish, experience may be considered in lieu of a degree.
Minimum 5 years of experience working in cGMP environment.
The candidate must have strong and effective interpersonal skills (both written and oral) and ability to communicate effectively with quality assurance, quality control, manufacturing, facilities, and other support staff.
Task and Team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multi-task is essential.
Takes initiative
Works well with all types of people

Nice To Haves

Experience with Flexicon automated fill units a plus.

Responsibilities

Participate in automated aseptic fill finish cGMP manufacturing activities.
Leads the formulation/fill finish tasks as required. Identify issues and propose adequate solutions.
Demonstrate technical expertise in Aseptic Techniques for Formulation, Aseptic transfer/Filtration and Filling, and equipment operation such as Automatic Fill Machine, Filter Integrity Tester, Autoclave, Analytical Scales, pH/conductivity meters, Peristaltic pump and more as required.
Experience with Flexicon automated fill units a plus.
Level 4/Aseptic gowning and extended period of fill finish process execution.
Perform Environmental Monitoring for Grade A/B during product fills per regulatory guidelines.
Equipment and tubing Assembly preparation related to the filling operation.
Cross train and participate in Upstream and Downstream operations as needed.
Provide expertise in writing/reviewing standard operating procedures, batch records, deviations, and other technical documents as it relates to the fill finish operation. Provide support for upstream and downstream document writing/reviewing as needed.
Maintain and foster an environment of safety in the laboratory by becoming trained in and adhering to the safety policies of the laboratory.
Comply with cGMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.
Work towards becoming SME and train other staff members as required.
Ensure that all processing equipment and instruments are identified and maintained as per internal approved procedures.
Communicate and suggest regular process improvement to management.
Work effectively with quality assurance, quality control, manufacturing, facilities and other support staff personnel.
Other duties as assigned.