QA Raw Material Compliance Specialist Job at Proclinical (Visp)

Specialist Iii, Quality Assurance (Raw Material Qualification)

Carex is partnering with a Pharmaceuticals industry partner to hire a Quality As...

Location

United States , Madison

Salary:

Not provided

Carex Consulting Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Chemistry, Biology, Biochemistry, or related scientific field preferred
5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical environment
Strong experience in raw material release, supplier quality, and/or material qualification
Working knowledge of 21 CFR Parts 210/211, ICH Q7, and global regulatory expectations (FDA, EMA, Health Canada)
Familiarity with ICH Q3, Q8, Q9, Q10, and Q11 preferred
Experience with EDMS and ERP systems in regulated environments preferred
Proficiency in Adobe Acrobat, Microsoft Office, and SmartSheet
Strong communication skills with the ability to engage professionally with external partners
Detail-oriented with strong organizational and prioritization skills
Ability to work independently and manage multiple priorities in a fast-paced environment

Job Responsibility

Support raw material lifecycle management, including drafting, editing, reviewing, and approving specifications and qualification documentation
Review raw material qualification protocols and reports and ensure adherence to periodic requalification cycles
Perform risk assessments evaluating impact to product quality, patient safety, and regulatory compliance
Partner with Supplier Quality Audits to support supplier qualification and requalification activities
Maintain the Approved Supplier List (ASL) within the eQMS
Collaborate with suppliers to resolve quality issues, discrepancies, and non-conformances
Review supplier change notifications and assess potential impact
Initiate and manage raw material-related change controls
Manage Supplier Corrective Action Requests (SCARs) in alignment with procedures and agreements
Support deviation investigations, CAPAs, and root cause analysis for material-related issues

Fulltime

QA Specialist II - Operations

The QA Operations Specialist II – Floor Support is responsible for providing QA ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific field
Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience
ASQ certification is a plus
Exposure to RCA, technical writing, and working with quality related investigations
Exposure to lean operation excellence highly desirable
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9

Job Responsibility

Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing
Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems
Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures
Batch record review for adherence to internal procedures and Good Documentation Practices
Support the evaluation and disposition of intermediates, finish bulk drug substance and drug product
Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient
QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
Co-ownership of nonconforming material investigations
Review of Quality Control environmental and utility monitoring data and test results

Fulltime

Qa Specialist 2

Primary function is the timely and efficient advanced review ensuring accuracy, ...

Location

United States , Rockford

Salary:

22.15 - 24.92 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a related field and/or 1-5 years of related experience and/or training
College-Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables
High Standard of Report Writing

Job Responsibility

Timely and efficient advanced review ensuring accuracy, completeness and compliance to in–house, customer and regulatory requirement, including data integrity
Record and maintain all related data and records in compliance with cGMP and ALCOA principles
Train other associates in data review for which expertise/competency has been demonstrated
On time completion of assigned training in ComplianceWire
Participate in internal Health and Safety audits including developing actions and follow up
Participates in internal, customer and regulatory audits
Maintains a high level of safety and highlights any potential unsafe act immediately
Participates in implementation and execution of continuous improvement activities
Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory
Knowledge of and adhere to all PCI, cGMP, and GCP policies, procedures, rules

What we offer

Eligibility for an annual performance bonus
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)

Fulltime

Sr Quality Assurance Specialist

This position is responsible for providing quality and technical support to the ...

Location

United States , Birmingham, AL

Salary:

Not provided

Evonik Industries

Expiration Date

Until further notice

Requirements

Bachelor of Science degree in Chemistry, Biology, or Engineering
Minimum eight years’ experience in pharmaceutical or medical device manufacturing, preferred
Minimum five years’ experience in a pharmaceutical or medical device Quality Assurance role preferred
Proficient computer skills, Microsoft Word, Excel, Access
High attention to detail, organization, and accuracy
Strong written and verbal communication skills
Good interpersonal skills
Knowledge of FDA’s cGMP and/or QSR quality system requirements
Comprehensive technical skills/knowledge
Applied statistics experience, preferred

Job Responsibility

Represent quality department on development project teams
Review and approve product and process-related documentation
Support the generation and justification of product and materials specifications
Provide support for the development of validation strategies and validation plans
Review/approve protocols and reports
Support Deviation / CAPA investigations
Support interdisciplinary teams for root cause analysis of quality deficits using known of problem-solving tools
Support product quality and System improvements activities
Support collection and analyze data to identify opportunities for quality improvement
Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints

What we offer

performance-based remuneration
occupational health benefits
hybrid and flexible working environments
attractive career paths
high-quality development programs

Fulltime

New

Senior Software Engineer

Where software meets the physical world. In 2022, Budbee and Instabox merged to ...

Location

Sweden , Stockholm

Salary:

Not provided

Instabee

Expiration Date

Until further notice

Requirements

Senior-level Software Engineering experience
Proficiency in Golang, or the confidence and track record to pick it up fast
Experience with working in a Linux environment
You think in business outcomes, not just technical solutions
Familiarity with cloud platforms like GCP or similar

Job Responsibility

Shape the architecture — Contribute to key technical decisions and drive solutions that balance robustness with speed of delivery
Work across the stack — Hands-on implementation from cloud services to hardware-adjacent software
Collaborate closely — Partner with product managers, designers, and engineers to refine requirements and build things that matter
Raise the bar — Code reviews, knowledge sharing, and continuous improvement of systems and processes

What we offer

Sky-High Office: Modern, newly renovated with 360° views over Stockholm
Rooftop Fridays: Wind down the week at our rooftop bar
Monthly Tech Breakfasts: Midweek talks, great food, smart people
Tech Demos: Regular showcases of the latest innovations
Games Room: Ping pong, shuffleboard, foosball, and karaoke
Hybrid Hours: Work patterns that fit your life
6 Months Parental Pay: Full support when your family grows
Birthday Day Off: Your day, your way — every year

Fulltime

New

Routing Associate - Part Time

We’re looking for a detail-oriented and solution-driven Routing Associate to joi...

Location

Sweden , Stockholm

Salary:

Not provided

Instabee

Expiration Date

Until further notice

Requirements

Strong problem-solving skills with a keen eye for detail
Comfortable in a fast-paced, changing environment
Interest in data and analytics to support better decision-making
A collaborative mindset – you value open and clear communication
Fluent in both Swedish and English, spoken and written

Job Responsibility

Ensure effective routes – Create and optimise delivery routes for maximum efficiency, timeliness, and cost-effectiveness
Deliver on our promise – Make sure all deliveries meet the agreed timeframe and quality standards
Collaborate closely – Work with courier partners, hub managers, and internal teams to keep operations aligned and efficient
Spot opportunities – Identify process improvements and help implement solutions that make a real difference

What we offer

A unique opportunity to gain real-world experience in logistics and route optimisation while contributing directly to our last-mile success
You’ll work with a supportive team in a company that’s constantly evolving
You’ll have the chance to pick up extra hours during peak periods

Parttime

New

Assistant Housekeeping Manager

Location

Malaysia , Putrajaya

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

High school diploma or GED
1 year experience in the housekeeping or related professional area. OR 2-year degree from an accredited university in Hotel and Restaurant Management, Hospitality, Business Administration, or related major
no work experience required.

Job Responsibility

Ensures knowledge and understanding of OSHA regulations are up to date
Oversees all lost and found procedures
Obtains list of rooms to be cleaned immediately and list of prospective check-outs or discharges to prepare work assignments
Inventories stock to ensure adequate supplies
Ensures guest room status is communicated to the Front Desk in a timely and efficient manner
Works effectively with the Engineering department on guest room maintenance needs
Understands and complies with loss prevention policies and procedures
Ensures all employees have proper supplies, equipment and uniforms
Assists in supervising an effective inspection program for all guestrooms and public space
Manages linen inventory and guest supplies and assists in the ordering of supplies as necessary

Fulltime

New

Senior Manager, Software Engineering

Our Company - At Teradata, we believe that people thrive when empowered with bet...

Location

United States , California

Salary:

178800.00 - 268200.00 USD / Year

Teradata

Expiration Date

Until further notice

Requirements

10-12+ years of software engineering experience, including 5+ years in engineering leadership roles
Proven experience leading UI or full-stack teams building large-scale, customer-facing enterprise products
Deep expertise in modern frontend development with React and JavaScript/TypeScript
Strong understanding of system design and integration with distributed backend services (Node.js, Java, or Python)
Experience delivering products in fast-paced, platform-oriented environments
Demonstrated ability to lead multiple teams and drive execution across organizational boundaries

Job Responsibility

Define and execute Teradata’s observability vision across AI applications, developer tooling, and platform services
Lead and scale teams responsible for telemetry collection, metrics, logs, traces, events, and observability intelligence
Establish a unified observability architecture that supports proactive monitoring, troubleshooting, and performance optimization at enterprise scale
Drive adoption of observability best practices across engineering teams, embedding observability into CI/CD, DevOps, and AI workflows
Partner with AI and automation teams to apply intelligent analysis, anomaly detection, and automation to reduce operational toil and improve MTTR
Set operating mechanisms, success metrics, and engineering standards to ensure reliability, scalability, and continuous improvement
Represent observability as a strategic platform capability that enhances customer trust, transparency, and differentiation

What we offer

healthcare
life and disability insurance plans
401(k)-retirement savings plan
time-off programs

Fulltime

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QA Raw Material Compliance Specialist

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