QA Supervisor Operations

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Company :

Location :
King of Prussia, Pennsylvania

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
As an QA Supervisor – Operations, you will provide first-line supervision to a team of quality assurance professionals; direct intervention, acting as advisor, facilitator and team member regarding a wide array of operational quality, regulatory compliance and quality systems for all aspects of manufacturing of biopharmaceutical products and perform related administrative duties. You will also participate in and lead investigations and resolution of issues/decision making, including quality metrics, working with production and other cross functional teams to do so. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: – Lead and support review of production and other control records using established procedures and guidelines to support lot release of raw materials, components and finished goods. – Lead and support special projects, such as validation, site priority, or new products as required. Attend meetings as a Quality representative and provide input and decision as required. – Review for abnormal trends or indications of major problems. Alert all relevant parties of the situation. – Lead and support employees that review of documents related to change management such as work order review. – Accountable for employee development and/or performance management through activities such as assignments and associated technical training programs. Organizes and conducts training sessions. – Perform and/or manage the review of technical documents for equipment and process validation. – Manages closure of Quality system records including investigations, corrective and preventative actions, and change control. Maintains a high level of competency with current and emerging digital platform (SAP, EBR, ACCUTRAC etc) – Is a developing SME of their area, participating in area tours, supporting local or regulatory inspections, resolving technical issues, and managing self and team deliverables on time. – Direct employees and /or update departmental documents such as SOPs as required. – Knowledge in cGMP, CFR and other regulations in order to assure quality compliance. – Assist junior staff with problem solving. Assist area manager with manpower planning, efficiency objectives, and implementation of new departmental strategies Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: – BS or BA in Biology, Chemistry, Engineering, Biochemistry, or related field – At least 2 years of industrial experience in quality organizations, either in operations or assurance functions. Preferred Qualifications: If you have the following characteristics, it would be a plus: – Experience in quality systems, including validation, documentation, compliance – Good written communication, organizational, and computer skills. – Good interpersonal and verbal skills – Ability to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC. – Ability to prioritize and decide appropriate course of actions. Effective at assessing information that is available and making decisions independently. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: – Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk. – Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. – Continuously looking for opportunities to learn, build skills and share learning. – Sustaining energy and well-being. – Building strong relationships and collaboration, honest and open conversations. – Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.