-
Senior Systems Specialist
1 day ago
Sigma Defense Norfolk, United States· Be one of the first applicants, read the complete overview of the role below, then send your application for consideration. · Sigma Defense is seeking an Senior Systems Specialist to work on an upcoming Navy contract in the Norfolk, VA area. · This is a contingent position tha ...
-
Senior Systems Specialist
5 days ago
Sigma Defense Norfolk, United StatesJob Description · Job DescriptionSigma Defense is seeking an Senior Systems Specialist to work on an upcoming Navy contract in the Norfolk, VA area. · This is a contingent position that is pending award of contract. This means that the position is subject to the successful award ...
-
Senior Cybersecurity Specialist
2 weeks ago
Liberty Mutual Insurance Portsmouth, United States Full timePay Philosophy · The typical starting salary range for this role is determined by a number of factors including skills, experience, education, certifications and location. The full salary range for this role reflects the competitive labor market value for all employees in these p ...
-
Senior Environmental Specialist
1 day ago
Flatiron Construction Norfolk, United StatesYou will support our Virginia District project and provide technical input on environmental monitoring and design or construction methods to ensure compliance with environmental specifications or regulatory standards. · Audits, analyzes and reports environmental performance to i ...
-
Senior Cybersecurity Specialist
2 weeks ago
Liberty Mutual Insurance Portsmouth, United States OTHERPay PhilosophyThe typical starting salary range for this role is determined by a number of factors including skills, experience, education, certifications and location. The full salary range for this role reflects the competitive labor market value for all employees in these posi ...
-
Senior Contract Specialist
2 days ago
General Dynamics NASSCO Norfolk, United StatesESSENTIAL · FUNCTIONS AND PURPOSE (Job Description) The Senior Contract Administrator serves as the primary interface with the government to administer contracts and resolve contract issues, and is the authorized signature authority for all contract documents. Within broad obje ...
-
Senior Billing Specialist
6 days ago
WIN Waste Innovations Portsmouth, United States OTHERWIN Waste Innovations is a waste management company committed to delivering essential waste management solutions to customers and communities supported by our team of 2,100 employees. We believe in preserving our environment for future generations while providing for today's need ...
-
Senior Regulatory Affairs Specialist
5 days ago
Laborie Medical Technologies Corp Portsmouth, United StatesWe believe that great healthcare is an essential safeguard of human dignity. · At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd li ...
-
Senior Court Operations Specialist
4 days ago
New Hampshire Judicial Branch Portsmouth, United StatesADMINISTRATIVE OFFICE OF THE COURTS · POSITION ANNOUNCEMENT #24-53 · Location Position Available Salary Range Closing Date · 10th Circuit Court · District Division · Portsmouth, NH · Senior Court · Operations · Specialist · $40,092 - $58,754.80 · Labor Grade: · 19 · Open until ...
-
Benefit Programs Specialist Senior
1 day ago
City Of Norfolk Norfolk, United StatesThe City of Norfolk's Department of Human Services is committed to improving the lives of children, families, and communities through comprehensive services that support the well-being of Norfolk citizens. · The Department of Human Services is seeking to fill · a Benefit Progra ...
-
Benefit Programs Specialist Senior
6 days ago
City of Norfolk, VA Norfolk, United StatesBenefit Programs Specialist Senior · Print ) · Apply · Benefit Programs Specialist Senior · Salary · $48, $79,765.00 Annually · Location · Norfolk, VA · Job Type · Special Project w/Retirement · Job Number · 12029 · Department · Human Services · Division · Division of Social Serv ...
-
Benefit Programs Specialist Senior
2 days ago
City of Norfolk, VA Norfolk, United StatesBenefit Programs Specialist Senior · Print ) · Apply · ? · Benefit Programs Specialist Senior · Salary · $48, $79,765.00 Annually · Location · Norfolk, VA · Job Type · Special Project w/Retirement · Job Number · 12029 · Department · Human Services · Division · Div ...
-
Senior Corrosion Control Specialist
3 days ago
Thor Solutions Norfolk, United StatesTHOR Solutions is actively seeking a Senior Corrosion Control Specialist to support an upcoming professional support services contract for the U.S. Navy in Norfolk, VA. The candidate will perform/support tasks requiring an advanced level of knowledge in U.S. Navy Surface Ship Rep ...
-
Corporate Communications Specialist, Senior
3 hours ago
Booz Allen Hamilton Norfolk, United States Full timeCorporate Communications Specialist, Senior The Opportunity: · As a communications professional in shared services, you know how to team with peers and leadership to understand communications needs and then leverage multiple platforms (e.g., writing, visualization in PowerPoint ...
-
VCI Portsmouth, VA, United StatesThe position of Senior Contract Specialist Lead Level IV requires knowledge in acquisition negotiations, and Contracting Administration Support · The contracting professionals shall be able to process and assist the contracting office with cradle-to-grave procurement actions of v ...
-
ADVANTAGE SCI Norfolk, VA, United StatesJob Description Position Title: Senior Contract Specialist Reports To: The Customer and Program Manager Clearance Type: Public Trust Work Location: Norfolk, VA Job Description: Advantage SCI is accepting applications for a senior contract specialist to execute all acquisition pre ...
-
Sigma Defense Systems LLC Norfolk, VA, United StatesSigma Defense is seeking an Senior Systems Specialist to work on an upcoming Navy contract in the Norfolk, VA area · This is a contingent position that is pending award of contract · This means that the position is subject to the successful awarding of a contract and will be conf ...
-
TQI Solutions Norfolk, VA, United States"TQI Solutions - thought leaders delivering innovative solutions for the challenges of tomorrow · " TQI Solutions is actively recruiting forward thinking thought leaders ready to join us in providing solutions that positively impact the success of our clients · TQI team members m ...
-
senior independent testing specialist
5 days ago
Wells Fargo & Company , NC, United StatesLead and coach other team members throughout multiple concurrent reviews. Establish and maintain strong relationships across IT&V teams, CRE and CCW lines of business, and Internal Audit. Lead and/or participate in planning, scoping, executing and re Specialist, Senior, Internal, ...
-
Senior Service Specialist
20 hours ago
Epiq Virginia Beach, United StatesIt's fun to work at a company where people truly believe in what they are doing · Job Description: · A Senior Service Specialist provides various administrative support to our clients which may include; copy, print, mail, hospitality, facilities and receptionist services. · RE ...
Senior QA Specialist - Portsmouth, United States - Lonza Biologics Porriño SLU
Description
United States, Portsmouth (New Hampshire)Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
The Sr QA Specialist, through their increased knowledge and proficiency, assists GMP associates by providing first response and real-time Quality Assurance support for operational areas directly or indirectly involved in the execution of GMP-related activities.
This role serves as a resource to less experienced team members.Key responsibilities include batch record review (paper and electronic), logbook review, analytical testing review, Quality Tag Outs, release of areas and equipment from product changeover and other GMP records as applicable, as well as coaching & mentoring the associates with GMP tasks.
The Sr QA Specialist acts as the eyes and ears of Quality Assurance within operational areas, helping to ensure that the facility is inspection ready and GMP operations and documentation are in compliance.
Key Responsibilities:
Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits.
Provide GMP guidance to Manufacturing for routine and non-routine issues. May elevate more complex issues to senior staff and Management
Respond to QA Hotline calls in support of GMP operations. Sr QA Specialist is able to make most simple GMP decisions independently. With some complex decision making, they are working with senior staff or management
Provide guidance and compliant decision making to junior staff
Document all items within QAOTF shift notes, provide follow-up for other shifts as needed.
Authorize placement and removal of Quality Tag Outs, release equipment from Product Changeover
Oversee label management including creation and issuance of final product labels
Represent QA in meetings or on project teams as sole department representative. Will gain buy-in on QA positions and commitments from senior staff and/or Management
Perform other duties as assigned
Key Requirements:
Degree in Life Sciences and/or relevant experience in a Quality Assurance Environment
5+ years of experience in roles of increasing responsibility within Quality
Has solid understanding of cGMP and ICH guidelines and requirements
Must possess a working knowledge and understanding of critical process steps and parameters - e.g. final product filling, cryopreservation, aseptic processing
Understands the concept of product clearance through process changeover
Knows the concept of deviation management and documentation
Understands the TrackWise, SAP, LIMS, SAP, Syncade and Microsoft Office systems
Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows whom to elevate to
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.Lonza is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
#J-18808-Ljbffr
