Quality Control Specialist to Bio-Works

Bio-Works is looking for a QC Specialist to join the Quality team. The Quality team consists of both QA and QC with two QC Specialists. The main task for the QC specialist is to ensure that all products produced, as well as intermediates and project samples/development samples, are planned for and tested according to valid QC methods and that they fulfil their specifications.

Daily tasks;

- Planning the daily and long-term QC work together, cross-functionally, with applicable colleagues.

- Handling/logging samples and QC results/trend data for incoming samples as agreed upon to ensure that allocated samples are tested timely according to methods specified in product specifications or other applicable plans such as from projects, process validations, method validations etc.

- Lead, drive and support non-conformities/exemptions (including laboratory investigations as applicable), change control errands, improvement proposals, CAPAs, risk management, supplier- and audit related activities, as well as document management and data integrity within the area of responsibility.

- Participate as a QC representative in (cross-functional) projects and meetings.

- Assuring QC-methods are validated according to current QMS and standards.

- Assuring QC instruments/systems are calibrated, qualified and/or validated according to current QMS and standards.

- Assisting in and/or write and review validation protocol and report as a QC expert.

- Assisting in and/or write and review qualification (IQ/OQ/PQ) protocol and report as a QC expert.

- Assisting in and/or write and review URS (User Requirements Specification) as a QC expert for purchase and follows the internal requirements for supplier qualification.

- Assisting in the establishment and set strategy for governing and improving quality documentation within the area of responsibility, e.g. analysis methods, plans and procedures.

- Lead the planning and execution of periodic reviews within the area of responsibility.

- Support audits within the area of responsibility.

- Mentoring new QC staff and/or QC staff for new tasks/responsibilities

QUALIFICATIONS 👩🏻‍🎓👨🏽‍🎓

- University degree in Engineering, Chemistry, Biotechnology or equivalent

- Previous experience from analytical work and various analytical methods and techniques

- Previous experience from a QC role within life science is desired

- Knowledge of ISO 9001 and/or GMP is meritorious

- Statistical knowledge is meritorious

- Business proficiency in English and good knowledge of Swedish

At Bio-Works, your drivers and motivation are important. To be successful as a QC Specialist at Bio-Works you need to have strong communication skills with experience to influence cross-functional teams within your area of expertise. The QC Specialist need to be meticulous, accountable, analytical and structured in the way of working. The role requires the ability to follow through with difficult assignments while focusing on results. Team working ability and flexibility are central to success as well as having a working style that shows a high level of both integrity, empathy as well as a positive and quality focused attitude.

WHAT WE OFFER 🧁
In addition to a fun role, you are offered the opportunity to join an exciting, growing company with delightful and competent colleagues. We offer you flexibility and the opportunity to work from home in combination with on-site work as needed. You will also be able to adjust your working hours so that your personal life can flow smoothly. We have breakfast on Mondays, fika on Fridays and like spending time together over lunches and at conferences.

GOOD TO KNOW 💡
Start: According to agreement
Employment form: Permanent, with 6 months probation
Scope: Full time (100%, 40h/week)
Location: Uppsala (Uppsala Business Park)
Bio-Works has a collective agreement according to IKEM.

APPLICATION 📤
Last application day is 2023-02-28. We do not accept applications via e-mail. We will process applications continuously which means the vacancy can be filled before the last application date, so please apply as soon as possible. The position requires you to be located in Uppsala or the vicinity. You also need to be a citizen in the EU/EEA/Switzerland region or have the authority to work in Sweden.

ABOUT US 🧪
Bio-Works enables scientists to achieve their purification goals, from laboratory research to large scale bioprocess production. Our vision is a biotech industry that embraces, develops and builds on new methods and novel ideas. WorkBeads™, Bio-Works’ next-generation, agarose-based products, are used to purify proteins, peptides and other biomolecules, resulting in purer therapies and safer diagnostics. Through collaboration with customers and partners, we develop purification solutions that make important medicines available and accessible to everyone.