Construct Quality Control Supervisor Ii Jobs

Functional proficiency with an electronic Quality Management System

Perform studies to assist in qualification of QC test methods.

Experience in cell culture including aseptic technique

Experience with Good Documentation Practices

Perform QC release testing on cell and media products.

Write/review/revise SOPs related to quality control testing including test methods, equipment use, maintenance and calibration.

Three or more years of industry lab experience with HPLC, GC, GC/MS, LC/MS, ICP-MS, NMR required

GMP and ISO experience a plus

Hands-on experience with Biovia LIMS/LES system strongly preferred, Cheminformatics experience a plus

Must be able to multi-task in a fast-paced environment and possess strong verbal and written communication skills

Responsible for troubleshooting basic issues with supervisory oversight

Responsible for basic maintenance of equipment

Reviews and revises testing and equipment procedures as needed. Performs equipment and procedure qualifications periodically.

Employ sound technical writing skills involving deviation reports, laboratory investigation reports, etc.

Perform or assist with other Quality Unit assigned activities related to MURR facility responsibilities associated with FDA, NRC, and DOT regulations.

Able to independently perform testing on multiple radiopharmaceutical batches manufactured on a weekly basis.

Assists peers with method development and validation activities.

Contribute to the proper maintenance and organization of the laboratory, laboratory equipment, supplies, records, and samples.

Work with managers, supervisors, and employees to deconflict work and resolve issues.

Perform additional duties unique to this position as assigned by manager.

Bachelors' degree or equivalent training and experience, plus a minimum of 8 years of related and progressively responsible experience.

At least 3 years’ experience at Department of Energy (DOE) complex preferred.

Demonstrated ability to manage multiple tasks, changing priorities, and apply leadership concepts with an emphasis on continuous improvement and team building.

Requires excellent verbal and written communication skills, and computer skills in MS Word, Excel, and MS Outlook.

Works with managers, supervisors, and employees to deconflict work and resolve issues.

Perform additional duties unique to this position as assigned by manager.

Bachelors' degree or equivalent training and experience, plus a minimum of 8 years of related and progressively responsible experience.

Minimum of 8 years of electro-optics, electronics, and progressively responsible experience preferred.

Demonstrated ability to manage multiple tasks, changing priorities, and apply leadership concepts with an emphasis on continuous improvement and team building.

Requires excellent verbal and written communication skills, and computer skills in MS Word, Excel, and Outlook.

Review data, identify discrepancies, and escalate issues to management

Participate in method qualification/validation activities as necessary

Analyze, document, and report experimental data in accordance with Resilience requirements

Perform method transfer and qualification activities

2-5 years relevant life science experience

Experience in mammalian cell culture

Highly organized and detailed with effective time management skills.

Perform other tasks as needed by laboratory management.

Support quality assurance investigations of product complaints with technical knowledge of the products and analytical instruments.

3-5 years of relevant laboratory experience.

Update and maintain the equipment logbook, electronic sample log, reagent inventory log, and external testing log daily.

Perform peer review of laboratory documentation to ensure compliance with laboratory SOPs and test methods.

Review QC analytical assays including method qualification and validation assays.

Typically requires a bachelor's degree and 2+ years of related experience in a GMP QC role.

Important Skills: MS Office, LIMS, SAP, Trackwise, Waters Empower, Thermo Fisher Chromeleon, EDMS, compliance and science understanding.

What Takeda can offer you:

Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation, and data trending.

Work in multiple departmental and cross-functional teams and projects; inspection and regulatory support.

Actively participates in method transfer activities between facilities within the organization or between organizations.

Actively participates in and leads investigation of out-of-specification laboratory results, when required.

Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.

Prepares and executes method transfer protocols, method verification/validation protocols as and when required.

Assists, as and when needed, senior scientists working in the laboratory.

Standardizes API for use as in-house reference standard as assigned.

Working knowledge of Microsoft Office.

Working knowledge of 21CFR820 and ISO 13485.

2-4 years of relevant work experience.

Prepare/assemble, review, and approve Device/Lot History Record (DHR/LHR) documentation to effect finished product release, to include Certificate of Conformance (CofC) issuance.

Maintain up-to-date DHR/LHR files, including electronic versions.

Prepare sterile disposable product for shipment to sterilizer, including all necessary / ancillary paperwork.

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Generous paid time off, including:

Highly organized and detailed with effective time management skills.

Perform other tasks as needed by laboratory management.

Support quality assurance investigations of product complaints with technical knowledge of the products and analytical instruments.

3-5 years of relevant laboratory experience.

Update and maintain the equipment logbook, electronic sample log, reagent inventory log, and external testing log daily.

Perform peer review of laboratory documentation to ensure compliance with laboratory SOPs and test methods.

Coordinate customer repairs Manage Document Change Control (DCR)

Manage product rentals and loaners

3-5 years’ experience in Quality Role.

Demonstrated Critical Thinking skills with focus on improved performance outcomes and positive business impact.

Working knowledge of FDA Quality System Regulations, ISO-13485.

Write and update Standard procedures in compliance to QMS

Able to manage and track assigned projects

Effective communication, documentation, writing and problem-solving skills

Strong computer skills including Microsoft Word and Excel

Strong skill set in HPLC is a MUST

Nexus employees earn 4 weeks’ vacation per year, and our benefits start on day 1!

Perform analytical testing of materials, finished product, and components - this testing will consist of wet chemistry and analytical chemistry techniques

Understanding of scientific principles, ability to communicate with peers and management.

Participates in the execution of method/material qualification and analytical improvement projects.

3+ years of relevant experience (B.S. Degree), 6+ years of relevant experience (A.S. degree)

Solid working knowledge of operations/quality systems utilized in QC operations/support teams (e.g. strong test method/scientific base).

Provides timely review of data and documentation generated for or by QC.

Ability to perform color differentiation testing.

Excellent time management skills and ability to work both independently and in a team environment

Compile data, analyze, compare, and summarize results. Utilize knowledge and experience to identify trends, performance issues or other concerns.

Previous experience troubleshooting equipment and testing processes. Background in statistical analysis and process capabilities a plus.

Education: Bachelor’s degree in Chemistry or equivalent in a life science or related field. Advanced degree highly desirable.

Good working knowledge of MSOffice applications and ERP systems with SAP preferred.

Perform routine maintenance on equipment, and, if needed, use troubleshooting techniques to solve issues with equipment performance, testing protocols or samples.

Knowledge of inventory management/ERP systems and Microsoft Office products.

Minimum of 2-5 years of relevant work experience required.

1+ years regulated GMP environment experience required.

Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.

Assure all Materials Control staff are current on existing compliance and training requirements, as well as industry best practices

Other duties, as assigned in accordance with company requirements.

Minimum Qualifications – Education And Experience

Preferred Qualifications – Education And Experience

Other projects or responsibilities as may be required.

1-3 years of previous experience in a laboratory setting

Familiarity with basic lab equipment and knowledge of lab safety protocols

Excellent organization, communication, and problem solving skills

Participate in qualification of software and equipment.

Knowledge of operation and maintenance of analytical equipment and the associated software.

Perform routine projects independently, compile accompanying reports and/or data summaries.

Bachelor’s degree in Life Sciences/Biology/Chemistry or related discipline.

Self-driven, organized, adaptable to change, and can work independently under minimal supervision.