QA Specialist
Omni Inclusive
50% onsite
Work Schedule: M-F(normal business hours)
• Provide Global Patient Services (GPS) system general support, data configuration approvals.
• Create and Maintain new Apheresis Accounts in Client electronic supplier system (Veeva-SQM).
• Create and Maintain documentation in Client electronic documentation system (Veeva-BMSDocs).
• Complete daily entry of data in the Onboarding Tracker tool.
• Interact with American and European technical departments both orally and in writing (English language required).
• Quality Operations and Systems Support including deviation management, change management, CAPA, compliance guidance.
• Contribute to the Key Performance Indicating metrics to ensure continuous improvement.
• This is intended to be a general job description and should not be considered as all-inclusive.
Direct reporting line to the Associate Director of the Global Quality Patient Operations and Apheresis Regulatory Vigilance, CTDO
• Specific Knowledge, Skills, Abilities:
Meticulous, precise, 3+ years with MS Office, fast learner, good communication skills
o Ability to think clearly and act in a decisive manner; communicate difficult observations in a calm and cogent manner.
o Interpersonal skills: good communicator, establishes a collaborative environment.
o Demonstrated ability to work independently or with groups of people/teams in a complex changing environment.
o Adaptable/flexible and able to deal with change.
o Enterprise mindset and external focus.
• Education/Experience/ Licenses/Certifications:
Minimum High School Diploma required
o Minimum of 4 years' experience in pharmaceutical industry or equivalent.
o Good organizational skills, including ability to follow assignments through to completion.
o Innovative, proactive, and resourceful; committed to quality and continuous improvement.
o Independent decision-making capability and ability to think conceptually and understand impact of decisions, and to work with minimal supervision.
o Excellent verbal and written communication skill (English)
• Travel: This position does not require travel
Vacancy posted 11 hours ago
Similar jobs that could be interesting for youBased on the QA Specialist in Summit, NJ vacancy
- ...Global QA Patients Operations SpecialistThe primary responsibility of the Global QA Patients Operations Specialist is to support the Onboarding and Maintenance of Apheresis Centers in Client systems and tools.• Provide Global Patient Services (GPS) system general support...SuggestedFlexible hours
$34.97 per hour
A leading staffing firm is seeking a QA CTO Label Specialist to join their team in Summit, NJ. This contract position demands a Bachelor's degree in Science and a minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment. Candidates should possess...SuggestedContract work- Spectraforce Technologies in Summit West, NJ seeks a Specialist for Sterility Assurance Quality on the shop floor. You will ensure aseptic procedures, review investigations, and apply quality risk-management principles to drive compliance and issue resolution. Requires...SuggestedShift work
- 6 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Job Title :QA Label Specialist Location : Summit, NJ Hours/Schedule : Wednesday - Saturday; 2nd Shift (4p - 2am) Type: Contract Overview The Quality Assurance...SuggestedContract workAfternoon shift
- BaseRock.ai in Berkeley Heights, New Jersey, is seeking a QA AI Specialist to ensure the quality of AI/ML systems, validate data pipelines, and verify AI-driven user experiences across products. You will collaborate with engineering and product teams, implement testing...SuggestedFlexible hours
- 1 00% onsite Job Title: CTO QA Label Specialist Shift: This position is scheduled for Wed- Sat (1 pm to 11 pm). The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the coordination...Shift work
- ...Products Business Use Case Testing (BUCT) Integration TestingAgentic qa Developer Resources BlogsWorkshopsProduct Documentation Use... ...insurance Unlimited PTO Great culture Career growth QA AI Specialist Focuses on quality assurance methodologies tailored to AI and...Full timeContract workFlexible hours
- ...QA SpecialistReporting to the AAA Site Remediation Lead, the AAA Remediation QA Specialist is responsible for GMP quality assurance oversight of remediation activities and the on-time execution of project deliverables, ensuring successful completion of remediation commitments...Local area
- Isotopia USA, a global biotech company, seeks a Quality Assurance Administrative Specialist at our Westfield, NY site. You will manage QA document control, ensure cGMP compliance, and support regulatory filings, with a focus on accurate records and efficient processes....
- QA/ QC Specialist, NJ Maryland Energy Advisors (MDEA) is a rapidly growing energy management firm supporting many of the region's largest businesses, including real estate owners, restaurants, manufacturers, and other commercial and institutional partners. We also provide...For contractorsFor subcontractorWork at officeRemote work
- ...SCOPE OF POSITION (Position Summary): The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations... ...a regulated cGMP environment. The primary focus of the QA Specialist role will be to support routine clinical and commercial...
- Jobtailor is seeking an experienced Quality Assurance professional to lead GMP-compliant API manufacturing quality activities in a complex clinical supply development, based in New Jersey. You will review and approve GMP documents, perform independent batch release decisions...
- ...delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be...Shift work
$60k - $74k
QA/QC Inspection Specialist - Residential Energy Program - ICF - NJ Support residential energy programs by ensuring quality and compliance through field inspections and QA/QC reviews. This role partners with contractors and stakeholders to verify installations, resolve...For contractorsFor subcontractorLocal areaRelocationFlexible hours- Schuman Cheese is seeking a QA Associate - Technical & Regulatory to support quality assurance programs, regulatory compliance, and technical documentation across our production and packaging operations. The role requires a bachelor’s degree in a related field and 1-3...
- Job Title: Quality Assurance Administrative Specialist Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical... ...system activities. You will serve as a key coordinator for QA documentation and records management, compliance with current Good...Shift work
- ...more interconnected world.Job Description The Quality Assurance Specialist II, Cosmetics and Hygiene, assists with the standardization and... ...to Quality. Create cross-training course list for North America QA to ensure qualified back-up QA support. QualificationsBachelor’s...Work at officeImmediate start
- ...manufacturing and QC related documents for manufactured media Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center Support cGMP and associated OJT training to QA and other departments to improve right the...Immediate start
$90k - $115k
...equivalent combination of education and experienceExperienceCandidates must show knowledge and proficiency in the Quality Assurance Specialist II role Candidate should demonstrate knowledge of regulations and standards such as: AABB, AATB, FDA (HCT/P, cGMP, cGTP), 21CFR12...Work at office$55 - $65 per hour
DescriptionThis role sits at the intersection of Data Management & Governance, enterprise data quality assurance, Responsible AI operations, data architecture, and technology risk management. The position is accountable for making quality and governance requirements executable...Contract workTemporary work- CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable...Full time
$19 per hour
...compliance with SQF and FDA regulations. How you'll make an impact Report and document any food safety or quality issues to the QA Manager and/or SQF Practitioner immediately. Conduct pre-operational inspections and review checklists to release production areas...Hourly payFull timeFor contractorsSeasonal workImmediate startFlexible hoursShift work- ...Quality Specialist The Quality Specialist is responsible for compiling, reviewing, and maintaining quality documentation and customer data packages to ensure compliance with customer and regulatory requirements. Working closely with Quality, Manufacturing, Planning...Work at officeLocal area
- Title: Quality Assurance Specialist Location: Newark, NJ (Hybrid) Duration: 06 months (Right to Hire) Description: This role sits at the intersection of Data Management & Governance, enterprise data quality assurance, Responsible AI operations, data architecture, and technology...
$27.85 - $33.5 per hour
Primary Purpose:The QA Associate - Technical & Regulatory is responsible for supporting quality assurance programs, regulatory compliance, and technical documentation within the organization. This role ensures products, processes, and documentation meet internal quality...Hourly payFull timeWork at officeRemote workWork visaMonday to Friday- Schuman Cheese in Elgin, IL is seeking a QA Associate - Technical & Regulatory to support QA programs, regulatory compliance, and technical documentation across products and processes. You will help maintain product specifications, manage documentation, and support audits...Full time
- ...individuals every year. We are excited to announce our Quality Assurance Specialist opening! The Quality Assurance Specialist will provide quality... ...the establishment and continuity of standards of operation. The QA Specialist will conduct internal audits at all sites and...Work at officeLocal areaMonday to FridayFlexible hours
- ...animal health GCP auditing experience. • Animal health GLP auditing experience. Job Title: Quality Specialist- II -Hybrid Job Location: Rahway NJ Duration: 2 years Provide QA oversight for a Global Research & Development organization. Serve as the Quality Assurance Unit...
- A leading IT staffing company is seeking a candidate with 0-3 years of GMP manufacturing or QA experience for a role in compliance and quality assurance. Responsibilities include ensuring adherence to regulatory requirements, coordinating batch records, and approving documents...
- QA Associate Onsite in Flanders, NJ and Fairfield, NJ Garonit Pharma is seeking a detail-oriented and collaborative QA Associate to support daily Quality Assurance operations and uphold our Quality Management System. This role is essential in ensuring product quality,...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to QA Specialist. Be the first to apply!


