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
Packaging Specialist Jobs
By Cella At , Framingham $25 - $30 an hour
Collaborate with the Senior Packaging Specialist on any photography and photography requirements for packages.
A minimum of 1-3 years design related experience.
Strong organizational, communication and presentation skills.
Prior retail packaging design experience preferred.
Compile and release any visual tools/artwork requested by both internal and external clients.
Responsible for adhering to all category deadlines, both internal and external.
Packaging Specialist Jobs
By Molson Coors At , Golden, 80401
Possesses the basic mechanical and technical skills to accomplish the required machine adjustments and maintenance.
Strong oral and written communication skills and the ability to work independently, as well as within a team.
Work within a fast paced and innovative company, meeting passionate colleagues and partners with diverse backgrounds and experiences
Reads and correctly interprets packaging schedules, understands, and follows job procedures, work instructions, as well as special notices and/or instructions.
May be required to work various shifts as determined by the business needs.
May be required to train and certify other employees
Senior Packaging Specialist Jobs
By Novartis At , Indianapolis $66,000 - $99,000 a year
Knowledge of procurement/inventory management systems and procedures.
Accurate/timely data entry for GXP documents.
Min. 5 yr in Packaging, Distribution, Warehousing, Manufacturing experience in a GxP environment. Hazardous shipping training a plus.
Fluent in speaking / writing in English. Proficient Microsoft Office and Computer skills.
Excellent customer service skills; displays a professional can-do attitude.
Your responsibilities include, but are not limited to:
Senior Specialist Packaging And Labeling (Contract)
By Vertex Pharmaceuticals At , $65 - $75 an hour
The responsibilities of this position may include, but are not limited to, the following:
Master and Executed Batch Record review and resolution of comments/issues
Archiving of batch documents in electronic document system
Track data for the purpose of metrics generation
Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
Disposition Decision and status change in Oracle
Senior Qa Specialist Jobs
By Neuralink At , Fremont, Ca $95,026 - $124,200 a year
Performs ongoing compliance audits using standard evaluation tools for audit/monitoring activities and ensures adherence to regulatory requirements.
Assists with monitoring activities involving the effective execution of corrective action requirements.
4+ years of experience in clinical quality assurance or related roles.
Proficient in Good Clinical Practice (GCP) guidelines and regulatory requirements.
Strong quality assurance and analytical skills.
Excellent communication and collaboration abilities.
Senior Qa Specialist Jobs
By Veranova At Devens, MA, United States
Work directly with production, project management, and quality control to ensure that deliverables meet quality requirements.
To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
Knowledge of and previous experience with GMP, ICH Q7, and 21 CFR Part 11 preferred.
Interact with contractor personnel regarding validation and qualification activities.
BS in a scientific discipline or equivalent with a minimum of 7-10 years’ experience in an GMP regulated industry.
MS in a scientific discipline or equivalent with a minimum of 5 years’ experience in an GMP regulated industry.
Packaging Specialist Jobs
By Green Dot Labs At Nederland, CO, United States
Affix all required labels according to requirements for each product
Work efficiently, manages time effectively
Adhere to all safety guidelines of packaging and handling of materials in the lab
Measure or weigh products in all forms into gram increments
Maintain consistent quality control standards
Weigh and package all items into appropriate containers
Packaging Specialist Jobs
By Green Dot Labs At Englewood, CO, United States
Affix all required labels according to requirements for each product
Work efficiently, manages time effectively
Adhere to all safety guidelines of packaging and handling of materials in the lab
Measure or weigh products in all forms into gram increments
Maintain consistent quality control standards
Weigh and package all items into appropriate containers
Packaging Specialist Jobs
By Green Dot Labs At Jamestown, CO, United States
Affix all required labels according to requirements for each product
Work efficiently, manages time effectively
Adhere to all safety guidelines of packaging and handling of materials in the lab
Measure or weigh products in all forms into gram increments
Maintain consistent quality control standards
Weigh and package all items into appropriate containers
Packaging Specialist Jobs
By Green Dot Labs At Fort Lupton, CO, United States
Affix all required labels according to requirements for each product
Work efficiently, manages time effectively
Adhere to all safety guidelines of packaging and handling of materials in the lab
Measure or weigh products in all forms into gram increments
Maintain consistent quality control standards
Weigh and package all items into appropriate containers
Senior Specialist Qa (Remote)
By Amgen At , Thousand Oaks, 91362, Ca $136,995 - $156,890 a year
Experience in project management, process improvement and quality system management
Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS
Manages and provides oversight of documents / records within the Quality Management System
Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
Manages external contractors providing services to the Digital QMS
Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities
Packaging Specialist Jobs
By Ardagh Group At , Houston, 77029, Tx

Did you know that Ardagh produce many of the beverage cans and bottles you drink your favorite beverages from?

Did you know we produce more than 160 million containers per day?

Senior Product Qa Specialist, Us&Can
By Trip.com Group At California, United States
Deliver presentations that persuasively communicate findings and recommendations to the management team and key stakeholders.
Monitor user experience metrics and provide local insights and advice to HQ teams.
At least two years of experience in user experience/operation/PM/quality assurance or related fields in the online e-commerce industry.
Strong written and verbal technical communication skills
Conduct local user research to explore local user behavior and preference.
Work collaboratively with other teams to solve users pain points.
Senior Qa/Qc Bim Specialist
By Parsons At , Remote $68,400 - $142,600 a year
Advanced experience with Autodesk's Navisworks Manage.
Must use creativity, independent judgment, and organizational and problem-solving skills to determine the best method to accomplish desired results.
3+ years of related experience
Previous quality and construction experience.
Experience using BIM 360 and/or other construction documentation platforms.
Strong verbal, written and electronic communication skills for responding to information requests.
Qa Specialist Jobs
By Joulé At Bothell, WA, United States
Reference material and critical reagents qualification protocols and reports
Perform the QA review/approval of technical documentation, including but not limited to:
Analytical method validation protocols and reports for in process, release, and stability testing
Analytical method procedures and associated change controls
Method technical transfer protocols and reports
Standard Operation Procedures and other controlled documents
Senior Qa Specialist, Csv
By ExcelGens, Inc. At Harmans, MD, United States
Bachelor’s degree in a Science or Engineering field with 6 years of experience or Master’s degree with 3 years of experience.
Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements
Able to work in a team setting and independently under minimum supervision.
Ensure site systems are compliant with the corporate Data Integrity program.
Provide QA support to enforce CSV guidelines, policies and procedures for control systems, automation, analytical equipment, and IT applications
Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives
Qa Specialist Jobs
By Botanic Tonics At Broken Arrow, OK, United States
Working with HR to ensure OSHA and safety requirements are being met
Experience in GMP manufacturing, QA/QC
Experience with 21 CFR 111, ICH Q7
Ability and experience working with regulatory agencies
Strong technical writing skills with proficiency in Microsoft Suite
Excellent communication skills are required (written and verbal)
Packaging Specialist Jobs
By pFriem Family Brewers At , Hood River, 97031, Or $17 an hour
Follow all checklists and guides provided by management
You’ll receive above market compensation with great benefits
You’ll also receive a monthly beer benefit of at least $200
Learn and adapt to how we do things in the packaging department
Learn to operate our bottling, canning and kegging equipment
Be willing to ask questions and discuss challenges to ensure proper execution of tasks
Qa Specialist Jobs
By VIZIO, Inc. At , Dakota Dunes, 57049, Sd
You have working knowledge of test management software, such as TestRail or Jira.
You have experience in project management and QA methodology.
You possess an analytical mind, critical-thinking skills, and problem-solving aptitude.
You have strong organizational skills and can meticulously follow detailed steps.
You have excellent verbal and written communication skills.
You ideally have previous experience as a Quality Assurance Tester or similar role.