No longer accepting applications
Quality Assurance Compliance Specialist
Germer International - Pharmaceutical RecruitingAllentown, Pennsylvania, United States8 days ago
Job type
- Full-time
Job descriptionResponsible for the review, approval, and disposition of finished product for the site and final CoA signature Facilitates client project management as required ensuring “quality on time and in full” Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed Leads or participates in focused deviation cross-functional investigations, improvement projects Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified Provides assistance to other QA associates and assists with department trainings Provides support to QA management during regulatory audits Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs Performs internal audits and assists in writing reports for audits Maintains and revises procedures related to the quality assurance activities Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining databases Maintains the vendor complaint process Maintains, monitors, and provides trend analysis of DIs, LIs, CAPAs, customer complaints, and change controls Performs special projects and / or assignments as indicated by Quality Management Oversees and reviews Obsolete material destruction Performs Quality inspections on packaging line as needed Maintains supplier approval program Supports / Maintains site Document Control System : Reviews, approves, and closes out Document Change Requests Tracks changes using DCC spreadsheet and supports actions through closure Maintains original documentation archive and archives documents offsite Prints new and revised documents; issues forms and logbooks Reviews documentation submitted for routing in eDMS for proper formatting and accuracy Loads documents into an electronic Documentation Management System (eDMS) Routes documents for approval in the eDMS Recalls documentation for audits in a timely manner Performs external audits and assists in writing reports for audits Responsible for maintenance and revision of procedures related to document control May require up to 25% travel Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems Excellent customer service skills and professional demeanor to interface effectively with all internal and external customers Excellent verbal and written communication skills Energetic, enthusiastic, and motivated disposition Attention to detail with strong organizational skills Ability to explain problems, solutions, make recommendations, and manage various urgent requests professionally Ability to analyze data / trends to make sound regulatory interpretation while preparing metrics and reports Ability to drive projects related to implementation of new workflows and system updates Bachelor’s degree in relevant scientific quality assurance / technical field 5+ years of experience Strong understanding of pharmaceutical cGMP, industry standards, and regulations Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels Expert level user for Quality computer systems Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems Thorough understanding of computer system validation and GAMP requirements
Senior Quality Assurance Compliance Specialist
Our client, a global leader in the development and manufacturing of generic injectable and inhalation products, is looking for someone to join their growing team that has an expertise in auditing and supplier onboarding.
Job Overview
- Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements.
- Provide proper control, review, and management of site documentation to ensure GMP and regulatory compliance.
Essential Duties and Responsibilities :
Key Competencies :
Education / Experience :
Create a job alert for this search
Quality Assurance Specialist • Allentown, Pennsylvania, United States
Related jobs
Focus on the core content of the job post, removing all extra metadata, navigation mentions, and other non-essential information.
Keep the content beautiful and concise, ensuring a high signal to no...Show moreLast updated: 30+ days ago
We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Construction Safety Specialist.
Safety Specialist to support heavy civil and highway cons...Show moreLast updated: 2 days ago We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Aggregate & Asphalt Quality Control Technician - South Reading.Aggregate and Asphalt Qua...Show moreLast updated: 30+ days ago 
FM Approvals is an international leader in third-party testing and certification services.We test property loss prevention products and services—for use in commercial and industrial facilitie...Show moreLast updated: less than 1 hour ago Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements.
Provide proper control, review, and management of site docume...Show moreLast updated: 30+ days ago 
Senior Quality Assurance Compliance Specialist.Our client, a global leader in the development and manufacturing of generic injectable and inhalation products, is looking for someone to join their g...Show moreLast updated: 6 days ago
Braun US Device Manufacturing LLC.Allentown, Pennsylvania, United States.Friday, Thursday, Wednesday, Tuesday, Monday.Other key product areas include nutrition, pharmacy admixture and compounding, ...Show moreLast updated: 9 days ago
Please review the job description below and contact me ASAP if you are interested.Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and pai...Show moreLast updated: 10 days ago
Position Name : Manager Quality Systems & Compliance.Position Summary : The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufactu...Show moreLast updated: 10 days ago
Senior Quality Assurance Compliance Specialist.Our client, a global leader in the development and manufacturing of generic injectable and inhalation products, is looking for someone with a strong b...Show moreLast updated: 2 days ago
Major Job Duties And Responsibilities (List In Order Of Importance) : Responsible For The Continual Improvement Of The Quality Management System.
Establishes, Coordinates, And Monitors The Quality Ma...Show moreLast updated: 10 days ago
The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all r...Show moreLast updated: 30+ days ago
We are seeking a highly skilled and experienced Packing Specialist to oversee and manage all aspects of packaging operations within the company.
This role combines strategic planning, leadership, an...Show moreLast updated: 10 days ago Please review the job description below and contact me ASAP if you are interested.Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and pai...Show moreLast updated: 10 days ago 
Quality Operations Inspector -I.Piramal Standard Operating Procedures (SOPs) and applicable regulatory requirements.This includes adherence to Good Manufacturing Practices (GMP), Good Documentation...Show moreLast updated: 6 days ago
Join Ecolab’s Bioquell Team as a.Bioquell seeks a committed, responsible Validation Technician to supervise and conduct professional, thorough equipment installations and validations within c...Show moreLast updated: 30+ days ago
The QC Manager oversees all aspects of quality control and calibration across machining operations.This role ensures compliance with internal standards and customer requirements, manages inspection...Show moreLast updated: 10 days ago
Join Our Team Keep Railcars Moving Safely & Efficiently.Were looking for a detail-driven, highly organized professional to support our mobile railcar repair sites.
In this role, youll help keep ope...Show moreLast updated: 30+ days ago Position Name : Manager Quality Systems & Compliance.Position Summary : The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufacturing, te...Show moreLast updated: 6 days ago Data Integrity and eCompliance Specialist.Data Integrity Compliance Officer (DICO), lead gap assessments of new and existing systems / practices.
perform DI risk assessments for identified gaps; perf...Show moreLast updated: 10 days ago
- Promoted
Manager Quality Systems & Compliance
PiramalSellersville, PA, USFull-time
- Promoted
Construction Safety Specialist
The H&K Group CareersSkippack, Pennsylvania, USFull-time
- Promoted
Aggregate & Asphalt Quality Control Technician - South Reading
The H&K Group CareersBirdsboro, Pennsylvania, USFull-time
- Promoted
- New!
Field Quality Assurance Compliance Auditor - Manufacturing
FMLansdale, PA, USFull-time
- Promoted
Senior Quality Assurance Compliance Specialist
PiramalBethlehem, PA, USFull-time
- Promoted
Quality Assurance Compliance Specialist (Allentown)
Germer International - Pharmaceutical RecruitingAllentown, PA, USPart-time
QA Quality Specialist II - Sys
B. Braun US Device Manufacturing LLCAllentown, Pennsylvania, United States, 18101Full-time
- Promoted
Quality Control Analyst I (Manufacturing / Quality) 1st Shift
Pyramid Consulting, IncSwiftwater, PA, USTemporary
- Promoted
Quality Compliance Manager
Piramal Pharma SolutionsSellersville, PA, USFull-time
- Promoted
Quality Audtior
Germer International - Pharmaceutical RecruitingAllentown, PA, USFull-time
- Promoted
CW Quality Specialist
StaffingPhillipsburg, NJ, USFull-time
- Promoted
Quality Compliance Director
MerckWest Point, PA, USPermanent
- Promoted
Packaging Specialist
DreamLine ShowerWarminster, PA, USFull-time
- Promoted
Project Specialist II
Pyramid Consulting, IncSwiftwater, PA, USTemporary
- Promoted
Quality Assurance Inspector (Sellersville)
Piramal Pharma SolutionsSellersville, PA, USPart-time
- Promoted
Validation Field Specialist
Ecolab Inc.Horsham, PA, USFull-time
- Promoted
QC Manager
BEC Machine ProductsHarleysville, PA, United StatesFull-time
- Promoted
Northeast Compliance & Inventory Coordinator
1st Response Rail Service, IncBoyertown, PA, United StatesFull-time
- Promoted
Quality Compliance Manager (Sellersville)
Piramal Pharma SolutionsSellersville, PA, USPart-time
- Promoted
Data Integrity and eCompliance
Germer International - Pharmaceutical RecruitingAllentown, PA, USFull-time