QA Clinical Supplies Specialist Job at Piper Companies (West Point)

Sourcing specialist

Alcura, a Cencora company, offers end-to-end clinical supply services and world-...

Location

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor's or master's degree in business administration, supply chain management, life sciences, or a related field
5 + years of experience in strategic sourcing or procurement roles, preferably within the pharmaceutical or healthcare industry- clinical supplies in a clinical trial environment
Strong analytical and problem-solving abilities
Effective communication and interpersonal skills
Strong understanding of clinical trials sourcing processes and regulations
Strong client building and 3rd party relationship management
Outstanding ability to provide customer service with the highest standards of quality and excellence
Fluent in English and Spanish- the hiring process will be conduct on this language.

Job Responsibility

Provide assistance during negotiations with suppliers/vendors to secure service level agreements (SLAs), and other relevant operational and quality terms while ensuring adherence to regulatory compliance specific to drug sourcing for clinical trials
Handling offers and orders with customers
Support the Sourcing Project Manager in coordinating end-to-end project management of drug sourcing initiatives for clinical trials
Requesting procurement-related documentation
Providing pricing and terms information
Assist in tracking project progress, monitoring timelines, and addressing any issues/risks that may impact deliverables
Review and maintain most up to date customer messaging at all times
Ensure all billing activities are forecast within the month
Collaborate with internal teams to gather necessary information for accurate client quotations, ensuring compliance with pricing guidelines and regulations
Analyze client requirements and project specifications to create customized proposals that meet their needs effectively

Fulltime

Batch Record Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Mexico , Mexico City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a related field
At least 3 years of relevant QA compliance and/or Quality Product Disposition experience in the pharmaceutical or biotech industry
Working knowledge of cGMP regulations
Experience reviewing manufacturing or clinical documentation

Job Responsibility

Support and execute quality oversight activities for Clinical Trial Materials manufactured at external CMOs
Ensure consistent application of quality compliance by aligning daily activities with applicable cGMP regulations (US, EU, and other regions as required)
Review batch documentation, supporting data, certificates of analysis, and technical reports for Finished Drug Product, clinical packaging, and labeling
Support batch disposition processes in accordance with established quality procedures and regulatory requirements
Facilitate and support deviation investigations, change controls, CAPAs, investigations, and nonconformance activities related to clinical manufacturing and external supply
Participate in inspection readiness activities and support internal, vendor, and regulatory audits and inspections
Identify, assess, and escalate product-related quality and regulatory issues and emerging trends
Work closely with Clinical Supply, Regulatory Affairs, Technical Operations, external Qualified Persons (QPs), and other stakeholders involved in external manufacturing and supply

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning options to help you save and plan with confidence for the future
Global Employee Assistance Programme (TELUS Health), providing 24-hour access to a worldwide network of over 80,000 independent, specialised professionals supporting you and your family's well-being
Life assurance
Flexible, country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, and more

Fulltime

Surgical Services Equipment Supply Technician

Registry/PRN - scheduled on-call, as needed, to help fill in for departmental ga...

Location

United States , Park Ridge

Salary:

19.80 - 29.70 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High school diploma or equivalent
Two years experience in supply management
Basic PC skills
Ability to communicate, both verbal and written
Ability to work in fast-paced environment with time constraints
Ability to lift heavy objects (up to and over 50 lbs.)
Ability to meet flexible work hours

Job Responsibility

Implements processes and procedures for supply/equipment evaluation and acquisition for Surgical Services
Implements Surgical Services inventory systems including complete case cart process
Responsible for accurately entering SSI supply data and maintaining supply database
Assists in Surgical Services supply acquisition
Participates in supply/equipment evaluation process
Monitors OR schedules to assure adequate provision of supplies/implants, instruments, and equipment
Acts as a liaison to physicians and Surgical Services staff with sales representatives in supply/equipment acquisition and maintenance
Follows policies/procedures pertaining to supply/capital acquisitions and regulation of sales reps presence in restricted areas
In collaboration with CPD staff, implements complete case cart processes, policies, and procedures
Works in collaboration with CPD instrument coordinator to assure adequate inventory of supplies/instruments

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Parttime

RN, Finger Lakes Occ Health Pgm

Provides direct support for Finger Lakes Occupational Health Services. Plans and...

Location

United States of America , Rochester

Salary:

35.35 - 45.96 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree in Nursing and 1 year of nursing experience required
Master's degree in Nursing preferred
Or equivalent combination of education and experience
3 years of nursing experience preferred
Multidisciplinary knowledge base, including but not limited to, Nursing science, Medical science, Occupational medicine, Epidemiology, Toxicology, Safety, Industrial Hygiene, Ergonomics, Social and Behavioral sciences and Business principles required
Strong process orientation required
Proficiency in MS Office applications required
Excellent communication skills required
Ability to work well in an interdisciplinary setting required
Basic knowledge of wound care and dressings required

Job Responsibility

Provides direct support for Finger Lakes Occupational Health Services
Plans and provides patient/client care and case management services
Develops and provides workplace programs and outreach to the community of occupational and environmental health and safety
Works collaboratively with clinical staff and physicians by planning, providing, and evaluating the care of patients/clients
Performs various tests following OSHA guidelines
Administers immunizations, provides patient educational material, and orders medical/pharmaceutical supplies
Provides direct patient care
Escorts patients to exam rooms
Reviews patient charts to anticipate health needs and organize flow
Obtains and records patient vital signs

Parttime

Specialist QA - Major Deviations

Let’s do this. Let’s change the world! In this vital role, you will serve as a Q...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of Manufacturing Support and/or Quality Assurance experience OR Bachelor's degree and 4 years of Manufacturing Support and/or Quality Assurance experience OR Associate's degree and 8 years of Manufacturing Support and/or Quality Assurance experience OR High school diploma / GED and 10 years of Manufacturing Support and/or Quality Assurance experience

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Serve as Quality investigation lead and decision-maker for complex Major Deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records
Demonstrate strong critical thinking skills, the ability to distinguish causal factors from root causes, and the ability to evaluate investigation quality using evidence-based decision making
Ensure that changes with potential impact to product quality are properly assessed and documented per established procedures
Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements
Ensure production records, laboratory results, and investigation documentation are complete, accurate, and compliant with cGMP standards
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to implement effective and sustainable CAPAs

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental & vision coverage
Life & disability insurance
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown

Fulltime

New

Specialist Quality Assurance – Drug Substance Deviations

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Quality Assurance experience
OR Bachelor's degree and 4 years of Quality Assurance experience
OR Associate's degree and 8 years of Quality Assurance experience
OR High school diploma / GED and 10 years of Quality Assurance experience

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Provides an additional QA oversight by critically reviewing and challenging deviation designations made at the shop floor to ensure accurate, consistent, and compliant classification
Collaborates with Manufacturing and cross-functional stakeholders to reassess impact, drive alignment, and support sound decision-making
Provides QA oversight by critically reviewing and challenging initial deviation write-ups to ensure accurate reflection of the event
Partners with deviation owners to strengthen event descriptions and ensure a clear, compliant initial resolution
Ensures that required sections, including further processing and continued operations, are completed accurately and within established timelines
Serve as Deviation QA Contact and decision-maker for deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions
group medical, dental & vision coverage
life & disability insurance
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans

Fulltime

New

Laundry Attendant

The Laundry Attendant is responsible for sorting, processing, and folding Rooms ...

Location

United States of America , Philadelphia

Salary:

Not provided

Four Seasons

Expiration Date

Until further notice

Requirements

Ability to work in a fast-paced, physically active environment
Strong attention to detail and quality standards
Team-oriented mindset with good communication skills
Basic knowledge of laundry operations or willingness to learn

Job Responsibility

Sort, wash, dry, and organize linens including sheets, towels, tablecloths, and napkins
Inspect linens and separate stained or damaged items for treatment or disposal
Operate ironing equipment and feed linens through to achieve a clean, finished presentation
Fold towels, robes, and other items using both manual and automated equipment
Maintain organization of clean linen inventory on racks and shelves
Operate and care for laundry equipment, reporting any issues to management promptly
Follow all safety guidelines and company policies while maintaining a clean work environment
Collaborate with team members to ensure efficient and timely linen processing

What we offer

Competitive wages and benefits package
Training and development opportunities
Complimentary employee meals
Uniforms and dry cleaning provided
Opportunity to work with a world-class team
Discounted
Medical, Dental, and Vision coverage
Parking and SEPTA access
City Fitness membership

Fulltime

New

Account Executive Development Program

The Account Executive Development Program is a 24-month developmental role desig...

Location

United States of America , Virtual

Salary:

115000.00 - 125000.00 USD / Year

Alight Solutions

Expiration Date

Until further notice

Requirements

3–5 years of experience in account management, client success, sales support, consulting support, or customer-facing roles (HR/benefits, healthcare, brokerage, SaaS, or related industries preferred).
Exposure to supporting employer or enterprise accounts (or comparable B2B clients) with multiple stakeholders
experience with 1,000+ employee accounts is a plus.
Strong written and verbal communication skills with the ability to present information clearly and professionally.
Demonstrated organization and follow-through: able to manage multiple priorities, maintain detailed notes, and meet deadlines.
Foundational problem-solving skills and comfort coordinating across teams to drive issues to resolution.
Growth mindset and curiosity to learn solutions, delivery processes, and consultative selling skills.
Comfort using CRM and productivity tools (e.g., Microsoft Office) to maintain account records, reporting, and documentation.
Collaborative, client-first approach with professionalism and discretion when handling sensitive client information.
Willingness and ability to travel as needed to support business objectives, including client meetings, team collaboration, and on-site engagements.

Job Responsibility

Support the Strategic Account Executive in managing day-to-day client needs, including meeting preparation, follow-ups, and action tracking.
Help build relationships with client contacts by providing timely responses, coordinating the right internal resources, and maintaining a high level of professionalism.
Assist with renewal and retention activities by gathering inputs, compiling materials, and supporting proposal/contract processes under guidance.
Coordinate internal partners (delivery, operations, product, finance, legal) to help resolve client questions, service issues, and escalations, ensuring clear ownership and deadlines.
Maintain account documentation (contact lists, meeting notes, risks/issues logs, success plans) and keep CRM/account records accurate and current.
Prepare standard reporting and performance review materials (service metrics, milestones, outcomes) and help summarize insights for client discussions.
Identify potential cross-sell/upsell signals (new needs, pain points, organizational changes) and route opportunities to the SAE and appropriate teams.
Learn and apply Alight solution knowledge and delivery basics to connect client needs to the right capabilities and next steps.

What we offer

health, dental and vision coverages starting Day One
wellbeing programs
retirement plans with contribution matching
generous time off
parental leave
continuing education
career growth opportunities

Fulltime

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QA Clinical Supplies Specialist

Job Description

Job Responsibility

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