Senior Quality Specialist, Gmp Qa Operations
By Agenus At Lexington, MA, United States
Working knowledge and technical understanding of the manufacturing and testing of biologics or Cell and Gene therapy highly desired.
Paper batch records (drug substance or drug product) review and batch disposition experience is a plus.
EnsuresthatManufacturing F acilities andEquipment arecompliant withcGMP requirements:
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Performs line clearances for all manufacturing runs in the Cleanroom. Must be willing to gown.
Verifies Leukopak Receipt. QA primary contact for verification of release of starting material performed by Supply and Logistics for GMP production
Enterprise Operations Mortgage Quality Control Specialist (Remote Opportunity)
By Regions At , Birmingham, 35203, Al

Thank you for your interest in a career at Regions. At Regions, we believe associates deserve more than just a job. We believe in offering performance-driven individuals a place where they can build a ...

Specialist, Quality Operations Jobs
By BioSpace At Alachua, FL, United States
Experience with using Quality Risk Management principles.
Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry.
Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
Ability to adapt to changing priorities and manage multiple assignments while meeting timeline.
Three (3) plus years of related experience in a regulated industry (vaccine, biologics, pharmaceutical)
Two (2) years of quality or GMP experience within a manufacturing organization
Senior Operations Specialist Jobs
By Chef Ann Foundation At Boulder, CO, United States
Strong project management skills, including time management and clear communication
Strong professional relationship cultivation and management skills that translate into building strong partnerships
Knowledge of and/or work experience in school food preferred
Could Manage the Operation’s Specialist and oversees goals of this focus area to ensure they deliver on the organization’s targeted outcomes
Ensure CAF initiatives are managed at the highest level and represent the organization’s commitment to quality, result-driven programming
Experience in program planning and development preferred
Quality Control Specialist Operations
By FUJIFILM At , Thousand Oaks, 91320, Ca $100,000 - $115,000 a year
Working knowledge of document management and lifecycle.
Advanced knowledge of Quality Management Systems (Deviation, CAPA, and/or Change Control)
Develop and implement procedures for effective data management.
Work with QC management to continually develop data management strategies.
Performs document management tasks for forms, procedures, and work instructions.
Performs document management tasks for writing reports, procedures, and work instructions.
Quality Control Senior Specialist
By Vertex Pharmaceuticals At , Boston, 02210, Ma $50 - $55 an hour
Experience using Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) to document and report results
Report OOT/OOS results and other deviations to area management.
Knowledge and experience in microbiology methods and/or aseptic techniques and sample collection.
Participate in executing method validations and/or classified areas qualifications.
Knowledge of various laboratory equipment including Microbial ID systems, Chemical Analysis, pH meter, and balance. etc.
Demonstrate good communication skills, both verbal and written, at all levels and across various functions.
Quality Operations Specialist Jobs
By Seagen At , Bothell, 98021, Wa $98,000 - $127,000 a year
Ensure label requirements for each country are defined
8 years professional work experience in regulated industry with Bachelor's degree, or 10 years' experience with Associate’s degree
8 years professional experience in Quality role in pharmaceutical or biotech company
Ensure overall compliance of Clinical and Commercial products for all regions
Ensure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and Recalls
Support product launch activities for introduction of product into new countries
Senior Associate, Research Operations-Quality Control
By Sarepta Therapeutics At , Columbus, Oh $83,500 - $104,500 a year
Sarepta Therapeutics offers a competitive compensation and benefit package.
Minimum of 2 years of experience performing QC data review is required
Minimum of 5 years of experience in a quality role is required, preferably in a GLP environment
Experience in immunology, molecular genetics, histology, and/or nonclinical studies is preferred
Strong writing and communication skills are required
Experience in document control is preferable
Senior Specialist Quality Control
By Seagen At , Bothell, Wa $103,000 - $133,000 a year
Experience with Blue Mountain, Maximo, or other equipment maintenance management system
Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner
Write and revise equipment and software related documents (user requirements specifications, qualification/validation protocols, etc.)
Work with QC, Facilities, IT, and QA to ensure equipment and associated software is managed in accordance with governing procedures
Excellent communication and collaboration skills
Experience using or managing analytical lab equipment (pH meters, balances, HPLCs, etc.)
Quality Control Engineer Wilson Nc, Usa Operations
By Philip Morris International At , Wilson, Nc

Be a part of a revolutionary change. At Triaga Inc., a fully owned subsidiary of Philip Morris International, we’ve chosen to do something incredible. We’re totally transforming our business and ...

Quality Specialist - Operations
By Molson Coors At , Fort Worth, 76134, Tx
You have working knowledge of statistical methods and computer skills
You have at least 2 years’ experience in quality related processes
You have advanced knowledge of the principles and techniques of microbiology and chemistry
You exhibit knowledge of laboratory equipment, instrument maintenance, calibration and trouble shooting
Possess a proven track record of achievement in a high speed, high volume manufacturing environment
Demonstrable evidence of driving World Class Supply Initiatives to deliver on challenging objectives
Ors Specialist 3/4 - Quality Control
By State of Louisiana At , , La $2,883 - $5,675 a month
Six years of full-time work experience in any field may be substituted for the required baccalaureate degree.
A maximum of 120 semester hours may be combined with experience to substitute for the baccalaureate degree.
30 to 59 semester hours credit will substitute for one year of experience towards the baccalaureate degree.
60 to 89 semester hours credit will substitute for two years of experience towards the baccalaureate degree.
90 to 119 semester hours credit will substitute for three years of experience towards the baccalaureate degree.
120 or more semester hours credit will substitute for four years of experience towards the baccalaureate degree.
Sr. Specialist, Quality Control
By Moderna At Norwood, MA, United States
Experience in authoring Chemistry and Bioassay investigations is preferred
Knowledge of General laboratory operations, Instrument and Software, Quality Events
Ability to think critically and demonstrate troubleshooting and problem-solving skills
Strong written and oral communication skills as well as very strong organizational skills
Knowledge of industry standards and guidelines
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
Specialist, Quality Control Jobs
By Moderna Therapeutics At , Norwood, 02062, Ma
Vacation, sick time and holidays
Volunteer time to participate within your community
Paid sabbatical after 5 years; every 3 years thereafter
Here’s What You’ll Bring to the Table:
Generous paid time off, including:
Quality Control Specialist Jobs
By NELOGIS At , Hagåtña, Gu

Performs quality control surveillances of processes, procedures, and conformance to contract requirements.

Specialist - Quality Control
By Novo Nordisk At , Fremont, Ca $80,670 - $141,170 a year
Data entry and review in electronics systems (ie. LIMs or PEMs)
Lead ad-hoc projects assigned by reporting manager
Experience writing standard operating procedures, specifications and other cGMP documentation, required
Experience with the application of cGMPs, USP/NF, EuPH., FDA guidelines and ICH guidelines with the pharmaceutical industry, required
Experience writing deviation and/ or change control, required
Experience in aseptic conduct and technique, preferred
Sr Business Control Specialist -Quality Analyst, Anti Money Laundering - Global Operations Chicago
By Bank of America At , Chicago, 60661, Il
Knowledge or experience with Anti-money Laundering concepts/regulations or ACAMS Certification
Strong communication abilities, organizational skills, and attention to detail
Proficient computer/software skills - Experience with Microsoft Word, Excel, Power Point, Outlook, SharePoint, etc.
Strong research and analytical skills – Ability to prioritize effectively, a self-starter, organized, capable of performing work independently with minimal direction.
Working knowledge of Risk, Quality Control/Assurance Framework
Previous work experience in one or more of the following areas: risk, compliance, audit, operations and/or controls
Quality Control Specialist (Clinical Operations)
By M3 USA At , Remote

M3 reserves the right to change this job description to meet the business needs of the organization

In 2020 M3 founded the ‘M3: