Associate II Quality Control
Associate II Quality Control
Jobdescription
For our client, an international company based in Solothurn, we are looking for a Associate II Quality Control.
The Quality Associate assures that all operations meet or exceed cGMP regulations. The position needs reactive support of discrepancy identification. This position will support quality key metrics and analysis. This role is expected to be cross-functional between all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments. Previous experience within GxP manufacturing will be an advantage.
General Information:
Tasks and responsibilities:
Your profile:
The ideal candidate has introductory experience in the pharmaceutical or biotech manufacturing sector, preferably with prior engagement in a GMP Quality Control role and familiarity in procuring quality-controlled goods. Additionally, you possess fundamental knowledge of Microbiology and Chemistry, along with experience in aseptic work environments.
Required Skills:
For our client, an international company based in Solothurn, we are looking for a Associate II Quality Control.
The Quality Associate assures that all operations meet or exceed cGMP regulations. The position needs reactive support of discrepancy identification. This position will support quality key metrics and analysis. This role is expected to be cross-functional between all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments. Previous experience within GxP manufacturing will be an advantage.
General Information:
- Start date: ASAP
- Duration: until 31.12.2024
- Extension: to be discussed
- Workplace: Solothurn
- Workload: 100%
Tasks and responsibilities:
- Management (preparation, moving, shipping) of QC test, stability & retain samples including trade and GMP compliant documentation including support of day to day operations within the site.
- Aliquotation & sub-sampling of drug substance bags to QC samples.
- Sample Shipment: Organize and coordinate sample shipment for raw material tailgate samples, material science tailgates, manufacturing science samples, analytical development and technical development samples as well as shipment to partner organizations and CLOs.
- Support day to day operations within the Central and WIP laboratories, including management of work orders for QC related non-analytical testing equipment like freezers.
- Ordering, management and distribution of QC related reagents and consumables through all QC laboratories on site, as well as management of QC labware.
- Authoring, reviewing and approving complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations etc.).
Your profile:
The ideal candidate has introductory experience in the pharmaceutical or biotech manufacturing sector, preferably with prior engagement in a GMP Quality Control role and familiarity in procuring quality-controlled goods. Additionally, you possess fundamental knowledge of Microbiology and Chemistry, along with experience in aseptic work environments.
Required Skills:
- Associate's Degree, technical degree (1-2 years), or Bachelor's Degree.
- Prior experience in pharmaceutical or biotech manufacturing environments, preferably in GMP Quality Control.
- Basic knowledge of Microbiology and Chemistry.
- Skills in buffer and solution preparation are preferred.
- Experience in aseptical working.
- Strong organizational skills and ability to work autonomously.
- Effective communication skills across all levels of management, peers, contractors, and external partners.
- Proficiency in typical productivity software (Word, Excel, Outlook, etc.).
- Preferably familiar with LabWare LIMS and Oracle systems.
- Dual language proficiency preferred, with a preference for German and English (minimum level B1).
Marta Bartkowiak
About the company
