Quality Assurance Manager, Site Operations
1 month ago
Summary
The Quality Assurance Manager, Site Operations Manager leads a team of QA Compliance/Operations Specialists responsible for supporting Lonza’s internal and external customers, with specific responsibilities for quality oversight of site Engineering, Facilities, Validation and QC functions as well as product disposition. The QA Manager ensures staff is meeting objectives and deliverables on time and in full and plays a key role within the site leadership team. This position supports the overflow of tasks as needed, assigns resources and priorities, ensures adequate training, coaches and develops staff, and evaluates performance.
Responsibilities
- Provides general direction and support and acts as a point of escalation for QA staff and customers.
- Ensures objectives are met and expectations align with Lonza SOPs, and regulatory requirements.
- Present and defend the Cleaning Validation program and acceptance criteria to Clients and Regulators.
- Review and revise the Cleaning Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.
- Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
- Utilizing an identified standard, independently review and approve in a Document Management System initial version and revised documents such as SOPs, Work Instructions, Forms & Checklists, Scanned Documents and others as needed.
- Review and approve electronic and/or paper Validation / Qualification documents such as Protocols & Summary Reports for
- Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.
- Review and approve non-DMS documents (QA Monthly Preventative
- Maintenance, Engineering Preventative Maintenance documents, CMMS
- Forms, Instrument Data Sheets, Functional Equivalent Memos, DMS
- Withdrawal Forms, Periodic Review Audit Trail and Misc. Facility Forms), etc.
- Attends Change Control Committee, Deviations Review Board and CAPA Board meetings as needed.
- Attends Site Quality Council and Lot Disposition meetings Quality Leadership meetings.
- Manages and tracks Key Performance Indicating Quality Metrics including batch release information for senior site management.
- Manages and leads (mammalian) Performs Lot Release/Disposition activities.
- Identifies and implements improvements to quality processes.
- Provides general direction for department. Develops team goals,
- monitors progress and ensures continuous improvement.
- Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.
- Participates in the hiring process, provides performance feedback,
- coaches, mentors and supports career development.
- Supports Regulatory and Customer Audits as needed.
- Perform other duties as assigned.
Qualifications
- Bachelor's Degree with 3 years exposure to a GMP regulated environment.
Reference: R62873
-
Quality Assurance Manager, Site Operations
3 weeks ago
Portsmouth, United States Lonza Full timeSummaryThe Quality Assurance Manager, Site Operations Manager leads a team of QA Compliance/Operations Specialists responsible for supporting Lonza's internal and external customers, with specific responsibilities for quality oversight of site Engineering, Facilities, Validation and QC functions as well as product disposition. The QA Manager ensures staff is...
-
Quality Assurance Manager, Site Operations
1 month ago
Portsmouth, United States Lonza Full timeUnited States, Portsmouth (New Hampshire) Summary The Quality Assurance Manager, Site Operations Manager leads a team of QA Compliance/Operations Specialists responsible for supporting Lonza’s internal and external customers, with specific responsibilities for quality oversight of site Engineering, Facilities, Validation and QC functions as well as product...
-
Quality Assurance Manager, Site Operations
1 month ago
Portsmouth, NH, United States Lonza Full timeUnited States, Portsmouth (New Hampshire) Summary The Quality Assurance Manager, Site Operations Manager leads a team of QA Compliance/Operations Specialists responsible for supporting Lonza’s internal and external customers, with specific responsibilities for quality oversight of site Engineering, Facilities, Validation and QC functions as well as product...
-
Quality Assurance Manager, Site Operations
1 month ago
Portsmouth, NH, United States Lonza Full timeUnited States, Portsmouth (New Hampshire) Summary The Quality Assurance Manager, Site Operations Manager leads a team of QA Compliance/Operations Specialists responsible for supporting Lonza’s internal and external customers, with specific responsibilities for quality oversight of site Engineering, Facilities, Validation and QC functions as well as product...
-
Quality Assurance
2 days ago
Portsmouth, United States Hutco Inc Full timeJob DescriptionJob DescriptionHUTCO, INC.Position: Quality Assurance (QA) Inspector - J1-J4Job Location: Norfolk, VAShift: All Shifts Available (Standard: M-F, 0600-1445)Security Clearance: No Clearance RequiredRate of Pay: $32.00 per hourDESCRIPTION:Hutco, Inc. is seeking an experienced Quality Assurance (QA) Inspector for our Quality Assurance department...
-
Residential HVAC Quality Assurance Specialist
2 weeks ago
Portsmouth, Rhode Island, United States QTL Holdings LLC - Recruiters for skilled residential & commercial trades Full timeJob SummaryWe are seeking a highly skilled Residential HVAC Quality Assurance Specialist to join our team at QTL Holdings LLC. This is an exceptional growth opportunity for individuals with a Rhode Island Master Refrigeration License.This role plays a pivotal part in the residential HVAC minisplit business unit of our top-tier electrical construction...
-
Quality Engineer
2 days ago
Portsmouth, United States Alexander Technology Group Full timeThe Alexander Technology Group is looking for a Quality Engineer with expertise in medical products. The ideal candidate will ensure compliance with regulatory standards and drive continuous improvement in product quality and safety.This is a fully on-site positionFull-time/permNO 3rd party c2c applicants will be consideredKey Responsibilities:Quality...
-
Quality Engineer
2 weeks ago
Portsmouth, United States Alexander Technology Group Full timeThe Alexander Technology Group is looking for a Quality Engineer with expertise in medical products. The ideal candidate will ensure compliance with regulatory standards and drive continuous improvement in product quality and safety.This is a fully on-site positionFull-time/permNO 3rd party c2c applicants will be consideredKey Responsibilities:Quality...
-
Senior Clinical Operations Manager
11 hours ago
Portsmouth, New Hampshire, United States ChenMed Full timeChenMed Job DescriptionWe are seeking a highly skilled and experienced Senior Clinical Operations Manager to join our team at ChenMed. This role is responsible for overseeing the clinical operations of our medical centers, ensuring that we provide high-quality patient care and meet our organizational goals.Job SummaryThe Senior Clinical Operations Manager...
-
Quality Control Inspector III
1 month ago
Portsmouth, United States Epsilon Systems Full timeEpsilon Systems Solutions, Inc. has a job opportunity for a Quality Control Inspector III in Portsmouth, VA.Summary:Directly reports to the QA Supervisor. Inspects and monitors work performed on government and commercial work items, specializing in Hull, Mechanical and Electrical Inspections for Quality compliance. Provide assistance to onsite management for...
-
Facilities Manager
1 month ago
Portsmouth, United States The Judge Group Full timeTitle: Facilities Manager Location: Portsmouth, NH Duration: 03+ Months (Contract to Permanent) Resource's typical working day: 3 sites you will be expected to travel between (All within 5 mins of each other) Constructions on site at moment - checking in with constructions. Coordinating vendors Answering work orders Coordinate and manage facility repairs and...
-
Facilities Manager
2 months ago
Portsmouth, United States The Judge Group Full timeTitle: Facilities Manager Location: Portsmouth, NH Duration: 03+ Months (Contract to Permanent) Resource's typical working day: 3 sites you will be expected to travel between (All within 5 mins of each other) Constructions on site at moment - checking in with constructions. Coordinating vendors Answering work orders Coordinate and manage facility repairs and...
-
Automation Quality Management Specialist
14 hours ago
Portsmouth, New Hampshire, United States Entegee Full timeJob SummaryA Quality Lead is required to oversee a team of Quality Engineers, ensuring the development, implementation, and improvement of quality assurance systems in a design and build manufacturing environment.Responsibilities:Lead a team of Quality Engineers to identify and analyze customer quality and technical requirements.Support the development,...
-
Quality Control Inspector III
2 months ago
Portsmouth, United States Epsilon Systems Full timeEpsilon Systems Solutions, Inc. has a job opportunity for a Quality Control Inspector III in Portsmouth, VA.Summary: Directly reports to the QA Supervisor. Inspects and monitors work performed on government and commercial work items, specializing in Hull, Mechanical and Electrical Inspections for Quality compliance. Provide assistance to onsite management...
-
Quality Control Inspector III
1 month ago
Portsmouth, United States Epsilon Systems Full timeEpsilon Systems Solutions, Inc. has a job opportunity for a Quality Control Inspector III in Portsmouth, VA.Summary: Directly reports to the QA Supervisor. Inspects and monitors work performed on government and commercial work items, specializing in Hull, Mechanical and Electrical Inspections for Quality compliance. Provide assistance to onsite management...
-
Information Assurance
2 days ago
Portsmouth, United States CompQsoft Full timeApply Description Title: Information Assurance (IA) Security SpecialistLocation: Portsmouth NHDuration: Full timeClearance: SecretClient: Naval Sea CommandCertification: CompTIA SEC+ CE or Equivalent Requirements Description:Formulates and assesses IT security policy to include business impact. Prepares security plans for...
-
Quality Control Inspector II
1 month ago
Portsmouth, United States Epsilon Systems Full timeEpsilon Systems Solutions, Inc. has a job opportunity for a Quality Control Inspector II in Portsmouth, VA.Summary: Directly reports to the QA Supervisor. Inspects and monitors work performed on government and commercial work items, specializing in Hull, Mechanical and Electrical Inspections for Quality compliance. Provide assistance to onsite management for...
-
Quality Control Inspector II
2 months ago
Portsmouth, United States Epsilon Systems Full timeEpsilon Systems Solutions, Inc. has a job opportunity for a Quality Control Inspector II in Portsmouth, VA. Summary: Directly reports to the QA Supervisor. Inspects and monitors work performed on government and commercial work items, specializing in Hull, Mechanical and Electrical Inspections for Quality compliance. Provide assistance to onsite management...
-
Quality Lead
2 months ago
Portsmouth, United States Entegee Full timeJob DescriptionJob DescriptionSummary: Quality Lead required to oversee Quality Engineers, ensuring development, implementation and improvement of quality assurance systems.Job Requirements:Degree in Manufacturing Engineering or similar technical discipline8+ years of experience in Quality, Engineering, or program management in a design & build manufacturing...
-
Information Assurance
1 day ago
Portsmouth, United States CompQsoft Full timeApply Description Title: Information Assurance (IA) Security Specialist Location: Portsmouth NH Duration: Full time Clearance: Secret Client: Naval Sea Command Certification: CompTIA SEC+ CE or Equivalent Requirements Description: Formulates and assesses IT security policy to include business impact. Prepares security plans for employing...