Our client is an ambitious player within the biotechnology industry and has been revolutionary in their approach of combatting life interrupting illnesses. Their sole purpose is to push the boundaries of modern science, to transform medicine and doing so with a singular focus on improving treatment results.
For our client, an exciting company in biotechnology, we are looking for a skilled Associate QA - Incoming Quality Assurance & Product Complaint Returns to reinforce the team in Breda.
* Knowledge, understanding and application of principles, concepts, theories and standards of technical/scientific field
* Specialized knowledge within own specialty area
* Deep technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
* Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
* Ensures compliance within regulatory environment
* Develops solutions to technical problems of moderate complexity
* Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
* Interprets generally defined practices and methods
* Works under general direction
* Work is guided by objectives of the department or assignment
* Refers to technical standards, principles, theories and precedents as needed
* May set project timeframes and priorities based on project objectives and ongoing assignments
* Recognizes and escalates problems
* Contributes to work group/team by ensuring the quality of the tasks/services provided by self
* Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup
* Provides training/guidance to others and acts as a technical/scientific resource within work group/team
* Establishes working relationships with others outside area of expertise
* Approve class 1 deviations related to IQA and WH related activities
* Perform complaint assessments in accordance with internal procedures, regulatory guidelines and business performance objectives.
Position Specific Tasks
* Initiate and own Minor deviations related to IQA/WH/Complaints Lab activities
* Provide QA oversight for regulatory labeling in the WH
* Destruction Authorizations
* Own training material related to IQA processes
* Own work instructions related to own processes
* Prepare metrics and own and maintain departmental performance boards
* Perform assessments in support of complaint investigations (e.g. Reserve sample inspection, Return sample inspection and Safety Features verification)
* Partner with corporate product quality surveillance, assessors from other sites and contracted partners to resolve product complaint investigations
* Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
* Assist in projects and improvement efforts as needed
* Provide training to ABR and affiliate staff on performing investigations/assessments
* Participate in site regulatory inspections of complaint sample handling process and in audits (internal and third party) as required.
What we offer
* Contract via Kelly for 12 months (40 hours per week)
* Start date: ASAP
* An exciting, ambitious, and international environment where you will be able to gain invaluable experience and where you will push the boundaries of science each day
Met betrekking tot deze functie fungeert Kelly Services als uitzendorganisatie. Wanneer je de beslissing maakt om op deze functie te solliciteren zullen jouw gegevens in overeenstemming met Kelly's Privacy Statement worden verwerkt.
Met oog op de AWGB (Algemene Wet Gelijke Behandeling) verwelkomt Kelly Services sollicitaties van iedere geschikte kandidaat, ongeacht etniciteit, geslacht, beperking, religieuze overtuiging, seksuele geaardheid of leeftijd.
Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.