New job Quality Assurance Manager in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Quality Assurance Manager in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Quality Assurance Manager in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com "Title: Manager, Quality Assurance - Focus Factory Location: Bedford, OH Responsibilities: - Provides oversight to the Quality Assurance floor auditing function with emphasis on promoting a Right First Time methodology for manufacturing processes. - Guides staff to provide timely resolution of Quality issues discovered during manufacturing of both Bedford and Contract products. Works with Production management for identification of root cause(s), impact assessment, and development of resolution strategies. Determines if a product requires segregation and/or evaluation for quality, safety, purity, or efficacy. - Oversees the Deviation assessment and disposition program for manufacturing related issues. Initiates investigations and provides final approval on deviations and ensures timely notification of issues to customers. - Responsible for the oversight of batch records in the Focus Factory. Responsible for resolving quality issues prior to product release. - Ensures staff development and talent management activities are in place with respect to Max Plans, Career Development and Succession plans. Mentors and develops direct reports through regular performance feedback and ensures performance management techniques are utilized throughout the department. Ensures all personnel are compliant with training requirements. - Reviews, approves and provides oversight to designated reviewers and approvers for manufacturing documents such as departmental SOPs, Change Control Requests and Batch Records. - Oversees Trackwise administration and ensures functionality after usage. Ensures all inquiries are addressed in a timely and correct fashion (e.g. Customer Complaints, Batch Record Inquisitions, Destruction Inquiries, and the progress of CAPAs within Factory). - Initiate new SOPs and/or Quality Programs, as necessary, as an outcome of internal QA audits and/or customer audit observations or project support requirements. New SOPs must be discussed with peers in other factories, as well as Quality. - Reports investigational and metrics findings to upper management, and, upon final resolution, provides the investigation report to the internal customer (Bedford Brand products) or contract customer. Initiates follow-up investigations, as necessary. - Participates in the Quality Improvement Process and supports the Quality Council and Compliance Dashboard meetings by supplying necessary data and information that represents the Quality function for the Focus Factory Requirements: - BS/BA degree in a science or engineering related field is required. - Minimum of 6 years of experience in the pharmaceutical industry with a focus on aseptic manufacturing is required. - Minimum of 4 years of experience in quality manufacturing is required. - Experience as a manager in a pharmaceutical environment is required. Desired Experience, Skills and Abilities: - Full knowledge and understanding of current Good Manufacturing Practices (cGMPs) as specified in the CFR's and USP/&EP Pharmacopoeia. - Experience in SOPs, MPRs, technical writing and must remain current in industry standards and best practices through training and literature review. - Strong communication skills, both oral and written coupled with strong presentation skills. - Computer skills should include Microsoft Office suite, with experience in other software programs relevant to this position. - Must have experience with internal and external customers with an appropriate level of administrative and technical expertise. - Experience gathering data and information for developing annual budgets, and meeting strict deadlines. Please email your resume to - dan.wienczkowski@rightthinginc.com"

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