• BS or BA preferably in a scientific or technical discipline.
• Minimum 5 year’s pharmaceutical / Biopharm experience in either in a techncial, operations or quality assurance role.
• Good written communication, organizational, and computer skills. Good interpersonal and verbal skills required.
• Previous project leadership experience in a Quality Assurance department.
• Previous experience in a management or supervisory role in the Quality Assurance department.
• Previous experience in quality systems, including validation, documentation, compliance department.
• Demonstrated knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements.
• Able to prioritize and decide appropriate course of actions. Effective at implementing decisions.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.
Why GSK? Because GSK’s Biopharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK’s Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance – Being accountable for quality and safety.
GSK Biopharm currently has an opening for a QA Specialist at the Biopharm manufacturing site located in Upper Merion, PA. Reporting to the Quality Assurance Manager, the purpose of this role is to develop, implement and administer input into in-process quality systems or electronic quality systems for the production of biopharmaceutical products to ensure compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role may lead a team of quality assurance professionals managing the quality systems. This role will act as advisor, facilitator and team member regarding regulatory compliance and quality systems for all aspects of manufacturing of biopharmaceutical products. This is done through direct intervention between this role and other staff in the facility. This role provides quality decisions to project teams and to routine operating teams. This position will provide guidance and training to new and existing employees in the Quality Assurance department and assist them with decision making.
• May supervise employees related to the review production and control records using established procedures and guidelines to support lot release of raw materials, components and finished goods.
• Lead and/or support special projects, such as validation, site priority, or new products as required.
• Assure completion of annual product reviews. Review for abnormal trends or indications of major problems. Alert all relevant parties of the situation.
• Collect and evaluate information to assist in internal and vendor audits. May conduct internal audits and prepare summary reports.
• Supervises employees that review of documents related to change management such as work order review.
• Advanced knowledge in cGMP, CFR and other regulations in order to assure quality compliance.
• Organizes and conducts training sessions.
• Perform and/or manage the review of technical documents for equipment and process validation.
• Manages and/or support closure of Quality system records including investigations, corrective and preventative actions, and change control.
• Direct employees and/or update departmental documents such as SOPs as required.
• Attend meetings as a Quality representative and provide input as required.
• Assist junior staff with problem solving. Assist manager with manpower planning, efficiency objectives, and implementation of new departmental strategies.
• Support implementation of global strategies as required by the GSK business.
• Provide as an interface with the local and corporate support or IT groups to facilitate implementation initiatives or problem solving.
You may apply for this position online by selecting the Apply now button.
GlaxoSmithKline is an equal opportunity employer, M/F/D/V - and we are proudly committed to diversity in our workforce.
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GlaxoSmithKline - 15 months ago
GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...