Our client is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Their bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide.
For our client, Herakles is seeking a QA Associate Lead, who is responsible to actively participate in the ISO 9001 Quality Management System. This role will be responsible for the management of Quality Associates in support of product release. The QA Lead will manage, mentor and motivate their direct reports. They are responsible for supervising the daily schedule and assigning tasks to their direct reports. Must work independently and manage short and long-term priorities. The Quality Assurance Lead will report directly to the QA Manager or Director.
They will work closely with the manufacturing team assisting with Quality Management Systems such as non-conforming materials, deviations and corrective actions. Demonstrates good judgement in selecting methods and techniques for obtaining solutions.This role leads the Quality Associates in the identification, review and approval of deviation investigations and Out of Specifications (OOS) results, root cause analysis and generate corrective actions to improve processes/systems.
The responsibilities of the QA Associate Lead are:
- Subject Matter Expert for Quality Management Systems and product line;
- The management of timely release of finished good products;
- Supervise direct reports which includes, setting objectives, monitoring performance and conducting reviews;
- Works with Subject matter experts, area managers and QA personnel to effectively manage and execute follow up on corrective actions, deviations and non-conformances, complaints;
- Assist with compliance audits (customer, supplier, internal, external);
- Manages daily schedule and communicates with peers and management for completion of tasks associated with product release;
- Gathering of KPIs for weekly and monthly senior management meetings;
- Final approval of quality investigations;
- Assist with the Product/Process Change Control process;
- Ability to lead quality meetings with multi-functional departments/individually to identify product;
- Ability to identify, detect and escalate quality related trends;
- Assist with the maintenance of the Repligen Quality Management Systems, as assigned.
Qualifications for the function as a QA Associate Lead are:
- Bachelor’s degree in Biological Science or other science related discipline;
- Minimum 5-7 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent;
- Ability to communicate with multiple departments and direct reports;
- Proficient in written and oral presentations skills;
- Shares timely information with peers on daily progress;
- Ability to contribute to and lead project teams;
- Focus and attention to detail is critical;
- Lead/Internal auditor certification preferred;
- Experience and knowledge of IT software platforms that support Quality Management Systems;
- Understanding of Good Documentation Practices preferred.
You live in the Netherlands and you are an EU citizen or alternatively you hold a permanent working permit
Interested in the position as a QA Associate Lead? Then apply via the button below or if you have any questions, contact the recruiter mentioned in the vacancy.