Quality Specialist
Katalyst Healthcares and Life Sciences
Summary:
McKesson is seeking a Quality Specialist with experience in Healthcare, Pharmaceutical, Medical Device, or Regulated Distribution environments to support Quality Management System (QMS) operations, supplier quality programs, quality agreements, SOP development, and regulatory compliance activities.
The ideal candidate will have strong knowledge of FDA 21 CFR Part 211, ISO 13485, supplier quality processes, and document-controlled QMS environments.
Roles & Responsibilities:
McKesson is seeking a Quality Specialist with experience in Healthcare, Pharmaceutical, Medical Device, or Regulated Distribution environments to support Quality Management System (QMS) operations, supplier quality programs, quality agreements, SOP development, and regulatory compliance activities.
The ideal candidate will have strong knowledge of FDA 21 CFR Part 211, ISO 13485, supplier quality processes, and document-controlled QMS environments.
Roles & Responsibilities:
- Support Quality Management System (QMS) activities and regulatory compliance initiatives.
- Manage customer and supplier quality questionnaires and supplier qualification processes.
- Review and support Quality Agreements, supplier contracts, and compliance documentation.
- Author, revise, and maintain SOPs and controlled quality documents.
- Support controlled substance compliance processes and regulatory requirements.
- Ensure alignment with FDA, DEA, ISO 13485, and internal quality standards.
- Maintain audit-ready documentation and records following ALCOA+ principles.
- Collaborate with Quality, Regulatory, Operations, Legal, and Compliance teams.
- 3-5+ years of experience in Quality, Compliance, QA, or Regulated Distribution environments.
- Experience in Pharmaceutical, Medical Device, Healthcare, or Life Sciences industries.
- Knowledge of FDA 21 CFR Part 211 and/orISO 13485 requirements.
- Experience with Supplier Quality, Quality Agreements, and Quality Questionnaires.
- Experience authoring and maintaining SOPs.
- Experience working within a document-controlled QMS environment.
- Strong technical writing, documentation, and audit support skills.
- DEA Controlled Substance compliance experience.
- Experience supporting supplier/customer audits.
- Experience with MasterControl or other eQMS platforms.
- ASQ CQE, CQA, or related certifications.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Quality Specialist in Guilderland, NY vacancy
- ...per weekYou see opportunities where others see processes. At Van Oord, you help shape a stronger quality culture across projects, teams and countries. As Program Specialist Quality, you improve the way we work every day through smarter standards, better collaboration and...Suggested
- ...Quality Specialist The Quality Specialist plays a key role in supporting daily quality operations to ensure products, materials, and processes consistently meet company standards and customer expectations. This position is well suited for individuals interested in...SuggestedLocal area
NESCO Inc
Schenectady, NY2 days ago $94.96k - $147.18k
...Job Overview Department/Unit: Quality Management Work Shift: Day (United States of America) Salary Range: $94,957.00 - $147,183.00 Position Purpose The Quality Specialist guides department managers, teams, and staff in the analysis, management, and improvement of the...SuggestedFull timeWork at officeShift work100 Albany Med Health System
Albany, NY3 days ago$75k - $80k
...Quality Improvement Specialist In the Quality Improvement Specialist role, you will be responsible for identifying, implementing, and managing cross-setting quality improvement strategies based within hospital, nursing home, home health, hospice, dialysis and physician...SuggestedHourly payContract workWork at officeIPRO
Albany, NY3 days ago- 100 Albany Med Health System in Albany, New York, seeks a Quality Specialist to guide teams in analyzing and improving organizational processes using CQI and PDCA principles. This role emphasizes managing clinical registries, regulatory compliance, and performance improvement...Suggested
100 Albany Med Health System
Albany, NY2 days ago $94.96k - $147.18k
## Quality SpecialistApplylocations: 66 Hackett Blvd Albany, NY 12208time type: Full timeposted on: Posted Todayjob requisition id:... ...States of America)Salary Range:$94,957.00 - $147,183.00The Quality Specialist is responsible for providing guidance to department managers,...Full timeWork experience placementWork at officeShift workAlbany Medical College
Albany, NY3 days ago$29 - $31 per hour
...Come join our amazing team and work from home! The Loss Mitigation Underwriting Quality Control Specialist primary responsibilities consist of reviewing the accuracy of work performed by the Loss Mitigation Underwriters including the review of approvals, denials, income...Hourly payExtra incomeWork from homeCarrington
Albany, NY4 days ago- ...Quality Assurance Specialist - Full Time About the Position: As a Quality Assurance Specialist , you will play a critical role in ensuring product quality and process consistency across manufacturing operations. This role supports quality assurance efforts through...Full time
All Star Auto Lights
Colonie, NY3 days ago - ...Job Description Position Summary As a Quality Assurance Specialist, you will play a critical role in ensuring product quality and process consistency across manufacturing operations. This role supports quality assurance efforts through process audits, document...Local area
TERREPOWER
Colonie, NY20 hours ago $67k - $83.2k
...Job Description Quality Assurance Specialist II - Albany, NY Build your future at Curia, where our work has the power to save lives. The Quality Assurance (QA) Specialist II is responsible for maintaining Quality databases and providing an on-the-floor QA presence...Contract workWork experience placementImmediate startcuriate.co
Guilderland, NY1 day ago- ...Mohawk Opportunities Inc. is seeking a Compliance Specialist to coordinate quality assurance activities and monitor compliance across programs in New York. The role includes audits of billing documentation, incident management support, and development of policies. The...
Mohawk Opportunities
Schenectady, NY2 days ago $76.44k
...make a difference and change the world. Job Description Job Duties: • Develop, implement, and maintain the project-specific Quality Assurance Surveillance Plan (QASP) in compliance with Federal Acquisition Regulations (FAR), Construction Quality Management (CQM)...Contract workFor contractorsWork experience placementFor subcontractorH1bImmediate startFlexible hoursCDM Smith
Albany, NY1 day ago$76.44k - $159.43k
...Job Description Develop, implement, and maintain the project‑specific Quality Assurance Surveillance Plan (QASP) in compliance with Federal Acquisition Regulations (FAR), Construction Quality Management (CQM) requirements, and contract specifications. Perform daily quality...Contract workFor contractorsFor subcontractorH1bFlexible hoursCDM Smith
Albany, NY3 days ago- ...Description ***ALL CANDIDATES MUST RESIDE IN THE NORTH EASTERN UNITED STATES*** As part of Osmose's expanding Quality team, we are seeking a dedicated Quality Specialist I to support our commitment to excellence in utility infrastructure services. This field-based role is...Monday to FridayNight shift
$70.14k - $135k
...If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.We are currently seeking a Senior Quality Assurance Analyst to join our team in Albany, New York (US-NY), United States (US).Overview of job:The Senior Quality Assurance (QA...Full timeTemporary workFor contractorsWork at officeRemote workFlexible hours- ...Quality Analyst Transform technology into opportunity as a Quality Analyst at GDIT. Shape what's next for mission-critical government projects while shaping what's next for your engineering career. Meaningful work and personal impact as a Quality Analyst, the work you...Weekly payWork at officeWork from homeFlexible hours
General Dynamics
Albany, NY3 days ago - ...End Client: New York State Department of Health (DOH) Job Title: Quality Analyst Duration: 30 Months Location: Albany, NY 12211 Interview Type: In-person Scope of Project The Software Analyst will support the Continuing Medicaid Eligibility Modernization Program under...
V Group
Albany, NY1 day ago $60.41k - $145.27k
...A nonprofit technology consulting company is looking for entry-level quality assurance professionals. The role involves evaluating business requirements, developing tailored validation plans, and ensuring compliance with performance standards. Ideal candidates should have...New York State Enterprise (NYSTEC)
Albany, NY2 days ago$70k - $90k
...Quality Assurance & Quality Control Specialist Position Summary The Quality Assurance & Quality Control Specialist plays a critical role in ensuring product quality, regulatory compliance, and manufacturing excellence throughout the production process. This position is...Work at officeNESCO Inc
Albany, NY1 day ago$24.85 - $32.8 per hour
...Job Details Job Location: Latham, NY 12110 Position Type: Full Time Salary Range: $24.85 - $32.80 Hourly Job Shift: Day Quality Assurance Specialist Salary Range $24.85/hr - $32.80/hr plus an Elite Benefit Package Summary: Drives service excellence and continuous improvement...Hourly payFull timeShift workWildwood Programs
Latham, NY4 days ago- ...Company Welcome to Ream Dream Paper Company, where we bring high-quality printing paper to life with a touch of humor and a commitment... ...is seeking a meticulous and dedicated Paper Quality Assurance Specialist. This unique role is perfect for someone with a keen eye for...
Ream Dream Paper Company
Rotterdam Junction, NY2 days ago $67k - $83k
...Quality Assurance Specialist II in Rensselaer, NY Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical...Contract workWork experience placementWork at officeImmediate startcuriate.co
Rensselaer, NY3 days ago$67k - $83.2k
...Quality Assurance Specialist II – Albany, NY Build your future at Curia, where our work has the power to save lives. The Quality Assurance (QA) Specialist II is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight...Contract workWork experience placementImmediate startcuriate.co
Albany, NY3 days ago$60.41k - $145.27k
...A nonprofit technology consulting company in Albany, NY, seeks a quality assurance consultant to evaluate business requirements and develop validation plans against client standards. This role requires expertise in quality assurance, effective communication skills, and...NYSTEC
Albany, NY2 days ago- ...maintains Knowledge Base content. Interacts with Fair Hearing Specialists to ensure that performance work standards are met or exceeded... ...Monitors Fair Hearing Specialists as they answer calls to assess the quality of their interactions with customers. Provides constructive...Permanent employmentTemporary workWork at officeRemote work
NYS Office of Temporary & Disability Assistance
Albany, NY2 days ago - ...Pramira is a premier general contractor delivering safe, high-quality construction services across California. With deep expertise... ...are seeking an experienced and detail-oriented Quality Control Specialist to support our fiber construction operations in the Palmdale area...For contractorsLocal area
$89.5k - $130k
...POSITION SUMMARY : The Quality & Patient Safety Specialist plays a key role in supporting the development, implementation, management and sustainment of an organization-wide system of quality and safety. Working with the Quality & Patient Safety team and organizational...Full timeFixed term contractWork experience placementWork at officeFlexible hours$67k - $83.8k
...Job Description Quality Control Analyst II in Rensselaer, NY - Nights Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering...Contract workWork at officeShift workNight shiftcuriate.co
Rensselaer, NY2 days ago- ...supporting pharmaceutical and biotechnology companies in the development and manufacture of small molecule therapies. We're looking for a Quality Control Analyst II to join an established analytical laboratory, supporting the testing of raw materials, in-process samples,...Relocation
Hartmann Young
Albany, NY3 days ago $19.62 per hour
Quality Assurance Associate Windsor, CO Pay: $19.62/hour Are you detail-oriented, quality-focused, and looking to grow your career in pharmaceutical manufacturing? We are seeking a Quality Assurance Associate to support manufacturing operations through inspections, documentation...Full timeWork at officeImmediate startMonday to FridayDay shiftAfternoon shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Specialist. Be the first to apply!
Related searches