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Lead Qa Technical Operations Jobs

Qa Operations Manager Jobs
By Novartis At , Indianapolis $107,200 - $160,800 a year
Provide daily leadership and management for the QA Operations Team.
Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
QA and QC experience in pharmaceutical or biotechnology pharmaceutical industry with environmental monitoring & cleanliness zones
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Quality And Technical Operations Remediation Lead
By Dechra Pharmaceuticals PLC At , Pomona, 91767, Ca $175,000 - $225,000 a year
Working with regulatory affairs to understand, interpret and agree on suitable CMC submission strategies for the life-cycle management of approved products.
Management and execution of sustainable performance improvements
Prepare and present project update reports to senior management as required
Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement
Previous experience working with FDA and participating in regulatory agency inspections
Extensive experience in quality, manufacturing or MS&T departments of a commercial pharmaceutical manufacturing company
It Technical Lead, Network Operations (Noc)
By Brightspeed At Charlotte, NC, United States
Technical Delivery and Integration management
Technical delivery and integration management
Lead and perform technical integration, coordination and delivery management involving Network Operations systems and applications
Work closely with senior management, analyzing long-term business goals and suggesting ways the organization might achieve these goals with technology
Telecom/Internet Service Provider Domain Knowledge and Network Operations Experience
We Offer Competitive Compensation And Comprehensive Benefits.
Qa Associate, Quality Operations
By Evotec At , Seattle, Wa
Possess effective task/time management organization skills.
Escalate to QA Operations management of any potential deviations, compliance risks.
Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment preferably in QA Operations.
Prefers candidate with QA Operations experience with On-The-Floor oversight
Excellent verbal and written communication skills.
Previous experience working in Quality Assurance, Quality Control, or Drug Substance or Drug Product manufacturing
Qa Operations Specialist Jobs
By Advanced Accelerator Applications At Millburn, NJ, United States
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
Support FDA/Regulatory interactions for the site activities and products to ensure successful regulatory submissions and inspections.
Technical Qa Analyst Jobs
By Cotiviti At United States
Participate on Agile Scrum teams to understand and influence software requirements to build effective test plans and improve end-product usability.
Bachelor’s degree preferred or equivalent 4 years’ work experience.
2+ years software testing experience in Quality Assurance or similar role.
HealthCare experience pertaining to Medical Claims processing is preferred.
Team player with strong desire to assist others and share knowledge.
Excellent analytical skills with ability to troubleshoot problems and find root causes.
Qa Operations Manager Jobs
By Novartis At , Indianapolis, In $107,200 - $160,800 a year
Provide daily leadership and management for the QA Operations Team.
Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
QA and QC experience in pharmaceutical or biotechnology pharmaceutical industry with environmental monitoring & cleanliness zones
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Qa Associate I - Operations
By PCI Pharma Services At Bedford, NH, United States
Knowledge and exposure to using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred
Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Cross functional staff, members of management, internal and external clients, members of the Quality organization
No managerial responsibilities. This is an individual contributor role.
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
Qa Operations Specialist Jobs
By Novartis At , Millburn, Nj $88,000 - $132,000 a year
2+ years of experience in a GxP Biopharmaceutical manufacturing operations
1+ years of experience in a quality assurance role
GMP/QA work experience conducting quality investigations, root cause analysis and quality risk assessment.
Strong organization, communication and presentation skills. Excellent interpersonal and communication skills.
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Qa Operations Technician Jobs
By Novartis At , Indianapolis, In $59,900 - $89,900 a year
2+ years of experience in a GxP Biopharmaceutical manufacturing operations.
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones.
Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH.
Knowledge of IT Applications & tools.
Knowledge of Quality Assurance, Quality Control (QC) Testing, Quality Standards.
Strong organization, communication and presentation skills, excellent and effective interpersonal skills.