The Round Lake, IL Takeda manufacturing facility is expanding! Come join our Quality Team!
This position will facilitate and manage the closure of CAPA investigations, issues, customer complaint investigations, projects, and general requests for data, information, and reports related to the Takeda Round Lake plant.
Process complaints which may include:
Determine reportability of a complaint and submit associated regulatory reports within regulatory requirements
Work with Product Surveillance to evaluate complaint for need to investigate and coordinate sample retrieval
Document investigation, batch review and sample evaluation results
Coordinate timely closure of complaints, as per procedure
Supports day to day management of the deviation and CAPA quality systems. Â
Ensure compliance to defined procedures and work with the facility to assess gaps and drive closure of implementation action plans.
Prepare monthly, quarterly and annual complaint metrics/ trending for quality reviews.
Maintain communication with Takeda facilities for batch release, document and data requests, coordination of inter-plant investigations, etc.
Coordinates product holds, FCAs, and BPDNs/BPDRs as needed
Supports annual product quality reviews, quarterly FDA reports.
Assists the facility in preparation for quality audits and participate in corporate audits and external inspections.
Works closely with manufacturing and product development teams and participate in proactive projects and teams that impact production, solve problems, improve quality, and provide support during investigations.Â
Other duties, tasks or projects as assigned.
Excellent interpersonal and communications skills; exceptional attention to detail
Ability to work well in a highly matrixed environment
Demonstrated experience in managing complex projects
Demonstrated knowledge of CAPA systems in cGMP environments
Strong knowledge of cGMP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
Training/experience in statistical tools, including lean and six sigma conceptsÂ
Excellent oral, written, presentation, and organizational skills, with the ability to handle a wide variety of tasks simultaneously with limited guidance
Proficiency in Trackwise, and MS Word, Excel and PowerPoint
Must not be allergic to Cephalosporins.
Education and Experience:
Minimum Bachelor's degree in the sciences or engineering
Minimum of 2 to 3 years of related work experience in a pharmaceutical or biotechnology organization in Quality, Regulatory, Product Development, or Manufacturing.
Mostly sedentary work, sitting at a desk and working on a computer
Walking through the manufacturing facility
90% working in an office environment / 10% working in manufacturing areas for investigations
Occasionally work in controlled environments requiring special gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment
May work in a cold, wet environment
May be required to work in a confined area
May be exposed to some Clean Room and cool/hot storage conditions
Location and Salary Information: This job posting excludes CO applicants.
USA - IL - Round Lake - Drug Delivery
Internal Number: R0031882
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.