- Time approval by Quality Assurance and on time closure of records.
- Verify.
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Site Quality Engineering Manager
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Lockheed Martin Andover, United States**Job ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**:Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Massach ...
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Site Quality Engineering Manager
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Lockheed Martin Corporation Andover, United States**JOB ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**: · Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Mass ...
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Quality Engineer
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Quality Engineer
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Bodycote Andover, United StatesQuality Engineer Our people are the heart of our business. As the world's largest provider of thermal processing services, Bodycote employs thousands of highly skilled staff around the globe, some of the best engineers, scientists, and technicians in the industry. Our staff is e ...
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Quality Engineer
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Senior Quality Engineer
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Senior Quality Engineer
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Senior Quality Engineer
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Senior Quality Engineer
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Quality Engineer Medical Device
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Senior Design Quality Engineer
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TransMedics, Inc. Andover, United StatesTransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCSTM) was developed to address the major limitations of the current standard of care, cold storage. The OCS S ...
Manager QA Compliance, Quality Engineer - Andover, United States - Sarepta Therapeutics
Description
The Sarepta Therapeutics QA Compliance Unit is seeking to fill a Full-Time position for Manager, Quality Engineer to develop and maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies.
Develop and maintain processes to facilitate QMS record completion through overseeing and enabling proper investigation including problem understanding, true root cause identification and effective CAPA to prevent reoccurrence.
This position will work cross functionally with quality assurance operations, quality control, manufacturing, validation, Manufacturing Science &Technology (MS&T) and external vendors to gather, analyze and interpret and report data from product manufacturing and testing as part of trending programs (e.g., Product Quality Review, Quality Event Trending, clinical manufacturing in process and release/ stability data, laboratory controls data) to address adverse trends/ gaps as part of continuous improvement.
This position will be responsible for tracking, management, and completion of cross functional area Quality Records (such as deviations, lab investigations, change control, and CAPA) in partnership with applicable SMEs and leads error prevention and continuous improvement initiatives based on identified recurring root cause.
Primary responsibilities include:
Develop and maintain Product Quality Review Management with Sarepta cross functional areas and vendors for annual data trending to allow issue resolution and process improvements including re-evaluation of product/ material specifications while driving closure within 90 days after reporting period and maintenance of up-to date/ accurate QTAsResponsible for triage/communication for significant events to Sr.
Leadership, tracking, management, and completion of cross functional areas Quality Records (such as deviations, lab investigations, change control, and CAPA) in partnership with applicable SMEs.
Leads error prevention and continuous improvement initiatives based on identified recurring root cause and implementation of effective CAPA.Serves as the Quality Record (PR) Subject Matter Expert (SME) for the designated departments.
e.g., Quality Control teamLeads complex technical investigations independently with occasional guidance and supportDrives closure of Quality Records by completing records per defined Standard Operating Procedures (SOPs) or by providing coaching and mentoring to record Authors and ContributorsReviews and approves records for quality and consistency to ensure Right-FirstMonitors, analyzes, and reports on quality record trends for the functional area to reduce non-conformance occurrences and recurrence over timeUtilizes quality record data trends, cGMP knowledge and Lean Six Sigma philosophy (i.e., Gemba Walk, 5 Why's, Pareto Analysis) to actively identify, drive and implement continuous improvement / error prevention initiatives within the functional areaProvides training on Root Cause Analysis to record Authors and Contributors as necessary.
Works on or leads other projects related to Error Prevent in response to identified CAPA.Develop and execute training qualification program for lead investigators to develop proficiency and knowledge commensurate with complexity of investigation level of minor, major, or criticalProactively identify current and future risk participating in internal Sarepta inspections and develop integrated action plans to mitigate and remediate adverse impactDevelop and maintain process for GxP quality management system SOPs and processes to identify potential gaps to Sarepta GxP and Corporate Policies for risk mitigation and remediation as appropriateReview and approve QMS record management to ensure timeliness, complete documentation, compliance, and effectiveness to SOPsContinue to improve on process to identify and resolve issues as part of QMS and Compliance Metric Program including monthly updates to cross functional QMS owners in preparation for quarterly Quality Review BoardPerform Quality technical review for change control submissionsSupport Regulatory Inspections and regulatory submissionsParticipate in special projects as assignedDesired Education and Skills:
B.S. or B.A.
degree (preferably in Life Science, Health Science or Biology) and five to ten years relevant experience in the pharmaceutical or biopharmaceutical industry (e.g.
, biologics) background and quality assurance (minimum of 5-10 years)
Quality professional with 5+ years of hands-on experience with increasing responsibility in a QA and/or Quality Engineering functionStrong Project Management skills/ experienceProficient in tracking and trending metrics for purposes of continuous improvement of processes and proceduresAbility to perform statistical analysisHighly motivated, strategic individual with compliance, quality assurance, and healthcare management expertiseAbility to increase personal responsibility whilst focusing on the empowerment and development of othersStrong interest to develop strategic process improvement plans to maintain operational excellenceExcellent leadership and management skillsSignificant GMP experience in either clinical and/ or commercial products, global experienceAcquired knowledge of US GxP compliance regulations and industry practices, as well as EU GMP requirementsAcquired knowledge of GMP Quality Management System (QMS) oversight for complianceExcellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholdersProficient in building consensus, negotiating, and escalating issues and risk managementUS FDA/EU inspection experience (participating or leading)Demonstrated continues improvement experience (i.e.
able to work with minimal supervision; demonstrate initiative and self-directionAbility to manage multiple concurrent projects and to deliver results accurately and on timeStrong interpersonal skills including teamwork, listening, giving feedback, giving instructions, and conflict resolution#LI-HybridThis position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e
