What are the responsibilities and job description for the Quality Control Technician position at Rentschler Biopharma?
Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.
We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!
Duties And Responsibilities
- Checks out pre-test samples and checks in post-test samples
- Assures proper storage conditions for sample types
- Reviews study sample to confirm consistency of labels, paperwork, and electronic system
- Responsible for the receipt and entry of samples shipped from external sites
- Performs any combination of sample management tasks, including labeling, preparing for shipping, transporting to labs and Supply Chain, inventorying, and discard
- Reviews and verifies sample paperwork against samples to ensure accuracy and communicate discrepancies. Distributes sample information and paperwork
- Verify data entry completed by others
- Takes responsibility for the inventory of reagents and consumables within the laboratory
- Performs daily instrument verification and maintenance
- Aseptic Aliquotation of samples
- Properly handles, stores, and disposes of hazardous materials according to OSHA and associated SOPs
- Ensures all work performed strictly adheres to cGMP, company, and client documents
- Basic maintenance and cleaning of lab equipment
- Inventory and discard of samples following SOPs
- Performs other duties as assigned
Qualifications
- High School diploma and 3 years of related experience, OR Associate Degree and 2 years of related experience, OR Bachelor’s Degree
- Ability to work in a clean room environment
- Excellent organizational skills along with good written and verbal communication skills, and attention to detail
- Proficiency in GMP's and ability to follow instructions and work as a team member
- Proficiency in office tools is a plus
- Proficient with MS Outlook, Word, Excel, and other electronic systems
- Exceptional communication and interpersonal skills
- Assists in training of QC laboratory staff, as needed
Working Conditions
- Laboratory environment working with chemical reagents and analytical equipment
- Personal Protective Equipment must be worn as required
- Entry into utilities rooms for water sampling
- Clean Room gowning and scrubs
- Normal office working conditions: computer, phone, files, fax, copier
- Minimum travel required (Less than 10% domestic)
Physical Requirements
- Frequent lifting up to 10 lbs
- Frequent standing/walking to work in lab environment for extended periods
- Frequent sitting for extended periods to use computer
