Quality Assurance Specialist Allentown PA
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Job Location:
Allentown, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Lets do this! Lets change the world!
This onsite position provides critical support for the Raw Material Center (RMC) warehouse based in Easton Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network serve additional manufacturing sites and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt incoming quality inspection and sampling environmental monitoring storage and transportation.
Responsibilities:
Ensure that all operations align with relevant regulations and Amgen requirements including Safety Good Manufacturing Practices (GMP) Good Distribution Practices (GDP) and Good Documentation Practices
Conduct sampling and inspection of incoming raw materials assess documentation and determine disposition
Review documentation associated with receipt storage and distribution
Approve GMP processes procedures documents and records addressing deviations CAPAs change controls risk assessments and validation records as required
Perform routine Quality Assurance assessments and provide direct operational oversight
Offer leadership guidance mentorship and training to staff and partner organizations
Manage oversight of logistic and transportation service providers
Provide expert advice on quality matters to operational teams and cross-functional groups
Ensure staff complete necessary training related to Amgen business operations
Achieve established metric targets and develop standardized approaches for tracking progress
Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
Participate in quarterly business and quality reviews and address any service failures with LSPs
Present updates on LSP Quality Management System health and initiatives at management reviews
Represent the Quality Unit during audits and inspections directly interacting with regulatory agencies
Support internal and external audits and inspections as a member of the audit/inspection team
Implement business continuity plans for services and processes
Form strategic partnerships with internal customers and external vendors to ensure operational success
Integrate risk management strategies into overall supply chain management
Lead initiatives programs and projects targeting operational improvements
Develop solutions that are comprehensive practical and align with functional goals
Perform additional duties as assigned by management
Lets do this! Lets change the world!
This onsite position provides critical support for the Raw Material Center (RMC) warehouse based in Easton Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network serve additional manufacturing sites and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt incoming quality inspection and sampling environmental monitoring storage and transportation.
Responsibilities:
Ensure that all operations align with relevant regulations and Amgen requirements including Safety Good Manufacturing Practices (GMP) Good Distribution Practices (GDP) and Good Documentation Practices
Conduct sampling and inspection of incoming raw materials assess documentation and determine disposition
Review documentation associated with receipt storage and distribution
Approve GMP processes procedures documents and records addressing deviations CAPAs change controls risk assessments and validation records as required
Perform routine Quality Assurance assessments and provide direct operational oversight
Offer leadership guidance mentorship and training to staff and partner organizations
Manage oversight of logistic and transportation service providers
Provide expert advice on quality matters to operational teams and cross-functional groups
Ensure staff complete necessary training related to Amgen business operations
Achieve established metric targets and develop standardized approaches for tracking progress
Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
Participate in quarterly business and quality reviews and address any service failures with LSPs
Present updates on LSP Quality Management System health and initiatives at management reviews
Represent the Quality Unit during audits and inspections directly interacting with regulatory agencies
Support internal and external audits and inspections as a member of the audit/inspection team
Implement business continuity plans for services and processes
Form strategic partnerships with internal customers and external vendors to ensure operational success
Integrate risk management strategies into overall supply chain management
Lead initiatives programs and projects targeting operational improvements
Develop solutions that are comprehensive practical and align with functional goals
Perform additional duties as assigned by management
Additional Qualifications/Responsibilities
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree OR
Masters degree and 2 years of quality assurance experience OR
Bachelors degree and 4 years of quality assurance experience OR
Associates degree and 8 years of quality assurance experience OR
High school diploma / GED and 10 years of quality assurance experience
Preferred Qualifications:
Proven ability to communicate effectively with cross-functional teams and diverse cultures both verbally and in writing
Academic background in Life Sciences Physical Sciences Applied Engineering or Manufacturing Technologies
Prior experience overseeing QA in distribution warehousing manufacturing validation and engineering functions
Expertise in managing deviations change controls and CAPAs
Proficiency in Veeva SM LIMS and ERP systems
Knowledge of industry standards (GMP GDP Import/Export)
Commitment to exemplifying Amgens core values
Demonstrated self-leadership and motivation
Strong critical thinking skills
Ability to evaluate compliance issues and engage with regulatory inspectors
Experience managing multiple priorities within a dynamic environment
Direct experience with drug substances and/or drug products
Advanced problem-solving abilities and capacity for scientific risk-based decision-making
Track record of representing an organization during regulatory interactions
High proficiency in Microsoft Excel Word and PowerPoint
What you can expect from us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.
In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:
A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts
A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Required Experience:
IC
Key Skills
- Invoicing
- Information Technology Sales
- IT Support
- Audio Visual
- Database Administration
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
