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

Specialist QA, Global Supply Quality

In this role you will be serving patients through internal collaboration with Am...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with 10 years of experience in manufacturing and quality management systems or a related field OR Bachelor’s degree with 12 to 13 years of experience in quality management systems or a related field
Minimum of 10 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations

Job Responsibility

Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type
Documentation review and approval including: supplier manufacturing records, investigation reports, Amgen quality records, and validation records (process & analytical)
Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles
Oversight and completion of supplier assessments and documentation to support product complaints
Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships
Review and approval of change control records for supplier changes
Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence
Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Take part in operational and quality improvement initiatives, programs, and projects
Develop solutions that are thorough, practical, and consistent with functional objectives

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

Team Leader

At Liaise, we are inspired by our values of Positive, Progressive, and Personal ...

Location

United Kingdom , Littleport

Salary:

13.75 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Strong communication skills
Takes pride in working with vulnerable people and takes safeguarding responsibilities seriously
Effective decision making and judgement
Strong planning and organisation skills
Successfully completed NVQ Level 3 in Adult Social Care (or equivalent)
Achieves all Health & Safety standards

Job Responsibility

Acting as a role model by leading and supervising carers day-to-day, working alongside them and completing regular staff appraisals
Ensure good team working
Motivate, support and mentor the staff when needed
Organising staff allocations and breaks
Promote the professional image of the services through excellent communication, appropriate behaviour and professional appearance

What we offer

Market leading pay rates
Length of service leave (up to five extra days holiday)
Fully funded Blue Light Discount Card
Access to Stream – our financial wellbeing app that lets you access your pay as and when you earn it, get discounts at supermarkets and helps you save
Employee Assistance Programme (access to free telephone counselling and legal advice)
Free compliance training, and opportunities to develop
NEST Pension Scheme
Free enhanced DBS check
Life Assurance (2 x salary)

Fulltime

Mobile Associate, Store-in-Store - Retail Sales

Mobile Associates, Store-in-Store are an integral part of the Retail Team respon...

Location

United States , Corona

Salary:

19.50 USD / Hour

T-Mobile

Expiration Date

Until further notice

Requirements

High School Diploma/GED (Required)
6 months of customer service and/or sales experience, Retail environment preferred. (Required)
Customer Satisfaction: Passionate customer advocate with the desire to be yourself when connecting and having fun with our customers. Effective at balancing customer experience and performance goals. (Required)
Team Building: Desire to be a part of the game-changing T-Mobile store team. Willingness to work alongside peers and store leaders, learning and sharing best practices, while serving customers and providing resolutions to issues. (Required)
Retail Sales: Competitive drive and confidence to succeed in a fast-paced sales environment. (Required)
At least 18 years of age
Legally authorized to work in the United States

Job Responsibility

Proactively engages with a broad range of customers in a highly-traffic retail environment. You will use digital tools, communicate effectively, educate customers, and showcase the value of T-Mobile solutions
As a Mobile Associate, you will consistently leverage digital self-serve tools during customer interactions and the onboarding process. You will identify customer needs and use solution-based selling techniques to fully demonstrate the value of T-Mobile products and services. By recommending wireless solutions, and an onboarding solution centric to helping customers understand how to self-serve and utilize the T-Mobile app for wireless needs, you will deepen relationships with customers and ensure their satisfaction
Complete training on the T-Mobile in-store experience, new skills, products and processes, and knowledge of systems and reference resources. Review your personal results, current promotions, and updates on the Hub to be Customer Ready at all times. You will continuously learn and improve your skills to provide the best possible experience for our customers. Partner with nearby store locations to properly/fully on-board customers. Will perform skills practicing, knowledge sharing, store operations, opening and closing procedures. As part of these procedures, you will carry keys to the kiosk cabinets, lock/secure kiosk and assets, and report any lost keys or assets to your manager
Customer obsessed. You are passionate, friendly, and engaging with customers. You are able to connect on a personal level, match the pace of the customer, build rapport, trust, and loyalty with every interaction. You are committed to providing exceptional service, and to exceeding customer expectations. You will proactively reach out to potential customers to further drive sales activity in your location. You are able to follow up with customers, capture referrals, manage Be Back processes, and build relationships with new and existing customers. As part of your role, you will have the ability to perform price overrides for our specialty offers specific to National Retail
Builds relationships with nearby leadership and teams to help support the customer experience from account set up, to device support and account servicing

What we offer

Annual stock grant
employee stock purchase plan
401(k)
free, year-round money coaches
Medical, dental and vision insurance
flexible spending account
paid time off
up to 12 paid holidays
paid parental and family leave
family building benefits

Parttime

Mobile Associate, Store-in-Store - Retail Sales

Mobile Associates, Store-in-Store are an integral part of the Retail Team respon...

Location

United States , Tyler

Salary:

18.00 USD / Hour

T-Mobile

Expiration Date

Until further notice

Requirements

High School Diploma/GED (Required)
6 months of customer service and/or sales experience, Retail environment preferred (Preferred)
Coaching (Required)
Communication (Required)
Consultative Selling (Required)
Customer Communications (Required)
Customer Education (Required)
Customer Engagement (Required)
Customer Needs Identification (Required)
Customer Referrals (Required)

Job Responsibility

Proactively engages with a broad range of customers in a highly-traffic retail environment
Use digital tools, communicate effectively, educate customers, and showcase the value of T-Mobile solutions
Leverage digital self-serve tools during customer interactions and the onboarding process
Identify customer needs and use solution-based selling techniques to fully demonstrate the value of T-Mobile products and services
Recommend wireless solutions and an onboarding solution centric to helping customers understand how to self-serve and utilize the T-Mobile app for wireless needs
Complete training on the T-Mobile in-store experience, new skills, products and processes, and knowledge of systems and reference resources
Review personal results, current promotions, and updates on the Hub to be Customer Ready at all times
Partner with nearby store locations to properly/fully on-board customers
Perform skills practicing, knowledge sharing, store operations, opening and closing procedures
Carry keys to the kiosk cabinets, lock/secure kiosk and assets, and report any lost keys or assets to your manager

What we offer

Medical, dental and vision insurance
Flexible spending account
401(k)
Employee stock grants
Employee stock purchase plan
Paid time off
Up to 12 paid holidays
Paid parental and family leave
Family building benefits
Back-up care

Parttime

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QA Raw Material Compliance Specialist

Job Description

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