Quality Compliance Specialist Job at 360 Resourcing Solutions (Keele)

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Experience working in Quality Function within the Pharmaceutical industry
Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
Basic Knowledge of the Pharmaceutical GxP regulations
Able to foster strong cross-functional relationships
Influence, interpersonal, verbal, and written communication skills
Able to respond positively to, and effectively implement, change
Digitally Savvy
Fluency in both English and Polish to handle communication with healthcare authorities in Poland
A degree or equivalent in a relevant scientific subject is desirable

Job Responsibility

Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
Batch Review all MIA Products Prior to QP Certification
Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
Investigation and resolution of complaints with CMOs
Determining and implementing robust CAPAs as required
Assessment and approval of deviations
Managing and approval of change controls
Creation and Maintenance of Quality / Technical Agreements
Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
Support of on-site audits and visits

Qa quality specialist

This position reports to the Associate Director, External Quality, Quality Syste...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in science or engineering
Minimum 3+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
Skilled in data analysis and excel
Strong communication and interpersonal skills – Oral, written and presentation skills
Works collaboratively with others to meet shared objectives.

Job Responsibility

Perform the Quality Systems Metric Review for External Quality and oversee relevant metrics and trending for each quality system to proactively drive on-time closure of Quality records
Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement
Responsible for development/reporting of metrics and supporting standardization of these across the Organization
Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO / External Quality
Deliver training on Quality Management Systems, as required
Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS
Identify and implement continuous improvement initiatives to the External Quality systems
Assist as needed in audits and inspections
Participate in development and implementation of global alignment projects with BioMarin’s sister sites
Manage the Self Inspection Programme for External Quality

Center Quality Specialist

Essential Job Responsibilities and Duties and Qualifications

Location

United States , Fort Pierce

Salary:

Not provided

Assessfirst

Expiration Date

Until further notice

Requirements

High school diploma, GED or equivalent required
Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required
Strong verbal and written communication skills
Must have above average problem-solving and decision-making abilities
Proficiency with computers
Must have explicit attention to detail
Must have excellent analytical skills, organization skills, and follow-up
Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Use hands to handle or feel objects, tools, or controls

Job Responsibility

Perform donor record file review
Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
Review medical reports and communication
Perform reviews of equipment incidents
Verification and release of sample shipment
Responsible for the inspection and release of incoming supplies
Initiate deviation reports as needed
Perform Weekly employee observations
Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
Reviews the documentation of unsuitable test results and the disposition of the associated units

Fulltime

Quality Specialist

We are seeking a dedicated Quality Specialist with experience in performing ship...

Location

United States , Houma

Salary:

Not provided

BOLLINGER MISSISSIPPI SHIPBUILDING LLC

Expiration Date

Until further notice

Requirements

Experience performing shipyard QA/QC functions OR 7 years of heavy manufacturing, craft experience (fitting/welding/paint/electrical/etc.), or shipyard related quality (testing/inspecting) experience
Strong understanding of quality assurance and control principles
Attention to detail and precision in inspection and testing tasks
Communicating procedures and processes in an effective manner
Effective communication skills, both written and verbal
Good problem-solving skills and ability to work independently or as part of a team
Proficiency in using standard software for documentation and reporting
Basic computer skills and proficiency in MS Outlook, Word, and Excel

Job Responsibility

Perform QA/QC functions to ensure compliance with industry standards and company requirements
Read inspection and test procedures, interpret codes, specifications, and advanced blueprints
Conduct inspections and tests according to established procedures
Follow written and verbal instructions accurately
Communicate procedures and processes effectively to team members
Utilize standard software (MS Outlook, Word, and Excel) for documentation and reporting

What we offer

Competitive Pay
Comprehensive Benefits Package
Pay for Skills
Career Development
Cutting-Edge Projects
Positive Work Environment & Company Values

Operations Compliance Specialist

Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

2+ years’ experience in technical writing and compliance
Proficient in data analytics, data visualization
Working knowledge in Regulations, GMP, GDP
2+ working within a regulated healthcare industry including a role in capacity of quality and compliance
Strong verbal, written and oral communication skills
Able to work independently and be flexible to changing priorities

Job Responsibility

Manage the authoring & drafting of all types of Manufacturing Operations documentation
Specifications & associated forms in conjunction with the various departmental subject matter experts (SME)
Support document updates and manage timelines for cross functional Projects
Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents
Organise & Facilitate Document Round Table meetings with cross functional teams as required
Mange and build Quality Veeva QMS metrics for Manufacturing Operations
Coach & Train colleagues in Documentation System & GDP queries
Support manufacturing operations on meeting deadlines on Veeva QMS records
Update compliance procedures and processes
Generate Reports/Metrics & analyze trends as required including but not limited to: Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics

SAP Documentation Quality Specialist

At LeverX, we have had the privilege of working on 1,500+ SAP projects, includin...

Location

Salary:

Not provided

LeverX

Expiration Date

Until further notice

Requirements

University degree in IT, Project Management, Linguistics, Technical Writing, or related fields
2–3+ years of experience as a Documentation Specialist, Quality Analyst, PMO Analyst, or SAP Project Coordinator
Understanding of Project Management methodologies
Good understanding of SAP project documentation types (BRD, FS, TS, Test Cases, Training Docs, etc.)
Proficiency with tools such as MS Office or Google Workspace, Confluence, SharePoint, Jira, and PDF/Word review tools (Track Changes, Comments, Version Control)
Familiarity with document versioning and approval workflows
English B2+

Job Responsibility

Develop and maintain templates, checklists, and formatting standards for SAP project documents (BRD, FS, TS, Cutover Plan, Test Scripts, etc.)
Guide project teams on documentation structure, compliance, and alignment with SAP Activate/ASAP/PMO methodology standards
Review documentation for completeness, accuracy, consistency, and adherence to corporate templates and terminology
Manage the document register and the review, approval, and release workflow
Prepare quality audit reports, identify non-compliance issues, and recommend corrective actions
Conduct training and collaborate with PMO to ensure transparency and high documentation quality across projects

What we offer

89% of projects use the newest SAP technologies and frameworks
Expert communities and internal courses
Valuable perks to support your growth and well-being
Employment security: We hire for our team, not just for a specific project. If your project ends, we will find you a new one
Healthy work atmosphere: On average, our employees stay in the company for 4+ years

Lead Project Controls Specialist - Quality

This position supports compliance with Capital Delivery project management polic...

Location

United States , New York

Salary:

94300.00 - 122256.00 USD / Year

AMTRAK

Expiration Date

Until further notice

Requirements

Minimum six (6) years of relevant experience in a quality control and\or assurance function and a Bachelor’s degree in Science or Engineering, or 10 years’ experience without a degree
Valid Driver’s License or ability to utilize an alternative method of transportation when needed to carry out job-related functions
Must have work authorization in the United States
Lean Six Sigma or process improvement training, certification, and/ or experience
Experienced in use of statistical analysis tools (Excel, SPSS, EngineRoom)
Familiarity with project management methods, techniques, standards, and best practices
Experience drafting technical documents such as standard practices, technical specifications, procedures, or policies
Ability to clearly organize and present reports, and other related technical information to upper management
Experienced in developing and delivering training

Job Responsibility

Prepare audit/compliance plans with sampling and test design for process measurement
Conduct audits, surveys, and performance reviews to ensure compliance with policies and best practices
Identify and recommend improvement opportunities across various management levels
Support development of corrective action scopes and monitor implementation
Conduct process mapping, quality checks, and audits to ensure data integrity and support data initiatives
Apply disciplined quality management common in manufacturing to construction projects
Identify gaps and inefficiencies and presents recommended improvement opportunities at various levels of management
Supports development of scope for corrective action or improvement projects
Track and monitor (or implement) corrective / preventive actions
Conduct process and value mapping activities

What we offer

health, dental, and vision plans
health savings accounts
wellness programs
flexible spending accounts
401K retirement plan with employer match
life insurance
short and long term disability insurance
paid time off
back-up care
adoption assistance

Fulltime

Supplier Quality Specialist

Join our globally growing team at ATS Industrial Automation where we create comp...

Location

Canada , Cambridge

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

A post-secondary technology diploma or equivalent, specializing in toolmaking, machining, welding or mechanical engineering, mechanical technologist, quality engineering or equivalent work experience is required
ASQ CQE or ASQ SSBB or equivalent work experience is required
Nuclear Auditor training and qualification
At least 5 years in nuclear environment or other highly regulatory industry
At least 5 years of quality assurance engineering experience in a manufacturing and/or fabrication environment
Experience with the Nuclear requirements relating to Quality and Inspection plans
Demonstrated ability to work independently and to manage multiple projects from various diverse organizations
Strong working knowledge and experience working with ISO 9001, N299, NQA-1,10CFR50, 10CFR21, N285, N286, B51 and ASME Section III guidelines
Commercial Grade Dedication background and experience
Capable of being certified to Jaeger-1 Test Chart and Bausch and Lomb Vision test (including color and far- and near-distance test)

Job Responsibility

Lead the charge in sourcing and developing top tier suppliers, by providing expert guidance on technology, performance, quality, cost, logistics and delivery
Partner closely with engineering teams and suppliers to drive innovation while elevating process and quality standards
Monitor industry advancements and recommend technologies that enhance cost effectiveness, product quality, and supply chain reliability
Be a catalyst for change by actively contributing to ongoing continuous improvement initiatives
Work directly with suppliers to boost their quality output and shipping performance
Champion ABM initiatives
Conduct supplier audits to ensure full compliance with relevant industry standards and certifications (ISO 9001, CSA N299, CSA N285, NQA-1)
Strictly follow CSA N285/NQA Quality requirements as defined within the manual and procedures
Existing Supplier Development to improve KPI’s (e.g. OTD, Conformance to Specifications, Receiving issues)
Perform rough cut capacity planning and resolve gaps at ATS Approved Suppliers

What we offer

Competitive starting salaries
comprehensive health and dental benefits
overtime pay
employee bonus
RSP matching
Employee Share Purchase Program
treat days
gourmet coffee and beverages
subsidized breakfast and lunches in our cafeteria
employee referral bonuses

Fulltime

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Quality Compliance Specialist

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