QC Raw Materials Scientist - Visual Inspection
We are looking for a detail-oriented and reliable Visual Inspection Scientist within the Quality Control unit to perform testing and inspection of incoming materials and biopharmaceutical products while maintaining the highest standards of quality and compliance within a GMP-regulated environment.
Passing a vision test with good eyesight (with or without corrective lenses) is a mandatory for this position.
Scope and Responsibilities:
- Performing visual inspection and compendial analyses of incoming primary packaging materials.
- Support site and manufacturing release objectives by performing visual inspections such as but not limited to stability, particle investigations, annual visual inspection, AQL testing and ad hoc investigations.
- Performing routine cleaning, verification and upkeep of laboratory and equipment.
- Performing stock checks related to visual inspection.
- Provide updates on sample storage and logistic needs.
- Demonstrate competency for visual analysis using observation methods such as but not limited to microscopy, light box, other relevant analytical instruments.
- Complete master laboratory records using good documentation practices (GDP).
- Identifying required document changes and participating in quality documentation updates as needed to allow for forward progress of production.
- Lead process improvements in conjunction with specialists and management.
- Provide training support for technical tasks and methods.
- Collaborate with colleagues to ensure all key performance indicators are being met including but not limited to testing, verifications, review, and/or document approvals
- Be able to work in accordance with GMP practices, conducting all activities in a compliant manner.
- Notifying line manager of identified deviations.
- Take part in deviation investigations
- Take part in setting up and executing CAPA plans.
- Take part in setting up and executing Change Control actions.
- Be aware of preparations for regulatory inspections
- Be aware of and comply with Alvotech´s current EHS policies
- Perform other assignments as assigned by management
Job requirements:
- Bachelor's Degree and 1-4 years of relevant GMP work experience preferred.
- Understand regulations and pharmacopeias associated with visual inspection.
- Experience with AQL sampling principles
- Understand the requirements of suppliers of GxP materials
- Communication skills: Excellent technical written and verbal communication skills.
- Strong collaborative spirit with team members
- Self- motivated, demonstrates commitment, technical and professional expertise
- Visual inspection literacy; understanding of defect identifications
- Maintain organized working space; comply with 6S lean standards
Specifics of the role:
- Regularly maintaining eyesight for inspection purposes. This should be demonstrated through a Keystone Eye Exam or an equivalent eye exam
- Be comfortable with gowning into clean room areas
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.