Quality Assurance Specialist II- Filling and Visual Inspection Training

Company: BioLife
Location: Athens
Posted on: November 16, 2020

Job Description:

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and the company quality practices.Leads ongoing, daily departmental operations.Provides on-the-floor support to filling activities in an ISO 8 environment. Oversees the aseptic techniques executed by manufacturing inside and outside of the filling isolator.May required to complete visual acuity test and support the visual inspection qualification program. Must be able to complete repetitive tasks for prolonged periods time.May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner. Interview/hire, evaluate, train and develop staff.Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.------Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.Support external assessments or audits.Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s).Other duties, tasks or projects as assigned.Education:Bachelor?s degree in the life sciences, --engineering or other related technical field --and experience with a pharma/ medical device or other similarly regulated industry preferred.Experience:-- Minimum of three (3) years of experience in biopharmaceutical industry preferred.--Strong interpersonal skills and great attention to detail are necessary.--Must be a strong team player with good problem solving, and good verbal and written communication skills.--Must be able to influence decisions based on regulatory knowledge.--Must have the ability to manage people, encourage teamwork and drive decisions.--Must be able to handle multiple projects concurrently. --Must have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.--Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint, TrackWise, Delta V, MES Systems)--Must have knowledge of FDA Regulations, Applications of Good Laboratory Practices, and Application of Good Manufacturing Practices. Must demonstrate excellent critical thinking skills and understanding of complex manufacturing processes and make risk based Quality Decisions on deviations based on knowledge of regulations and regulatory trends. Work with manufacturing, engineering, and quality systems group as primary job function. Must be able to work swing shift, some weekends, and holidays to support manufacturing.Notice to Employment / Recruitment Agents:Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda?s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Equal Employment OpportunityShire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEO is the Law ? Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdfPay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdfReasonable AccommodationsShire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Keywords: BioLife, Athens , Quality Assurance Specialist II- Filling and Visual Inspection Training, Other , Athens, Georgia