Talent.com
Quality Assurance Compliance Specialist

Quality Assurance Compliance Specialist

Germer International - Pharmaceutical RecruitingAllentown, PA, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

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 :

  • Responsible 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

    • Key Competencies :

  • 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

    • Education / Experience :

  • 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
    • serp_jobs.job_alerts.create_a_job

    Quality Assurance Specialist • Allentown, PA, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    QA Quality Specialist II - Sys

    QA Quality Specialist II - Sys

    B Braun MedicalAllentown, PA, United States
    serp_jobs.job_card.full_time
    Braun US Device Manufacturing LLC.Allentown, Pennsylvania, United States.Friday, Thursday, Wednesday, Tuesday, Monday.Other key product areas include nutrition, pharmacy admixture and compounding, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Print Quality Assurance Specialist - 2nd shift : 3pm-11pm

    Print Quality Assurance Specialist - 2nd shift : 3pm-11pm

    IWCOWarminster, PA, United States
    serp_jobs.job_card.full_time
    Primary Duties / Responsibilities : .QC checks, verify QC pull compliance, and collect and file QC.Conduct process audits and provide training on new and existing process compliance as needed.Enter qua...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Quality Compliance Manager

    Quality Compliance Manager

    Piramal Pharma SolutionsSellersville, PA, United States
    serp_jobs.job_card.full_time
    Position Name : Manager Quality Systems & Compliance.Position Summary : The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufacturing, te...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Quality Compliance Manager (Sellersville)

    Quality Compliance Manager (Sellersville)

    Piramal Pharma SolutionsSellersville, PA, United States
    serp_jobs.job_card.full_time
    Position Name : Manager Quality Systems & Compliance.Position Summary : The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufacturing, te...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Quality Control Inspector I - 3rd Shift

    Quality Control Inspector I - 3rd Shift

    B. Braun US Device Manufacturing LLCAllentown, PA, United States
    serp_jobs.job_card.full_time
    Braun US Device Manufacturing LLC.Allentown, Pennsylvania, United States.Friday, Thursday, Wednesday, Tuesday, Monday.Other key product areas include nutrition, pharmacy admixture and compounding, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    AAA Retail Membership Sales Specialist

    AAA Retail Membership Sales Specialist

    AAA Club AllianceFlemington, NJ, US
    serp_jobs.job_card.full_time
    Unlock Your Sales Potential at AAA Club Alliance! Are you passionate about delivering exceptional service while driving sales success? Join our team and be part of a dynamic retail environment wher...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Continuous Improvement Manager

    Continuous Improvement Manager

    Boston Beer CorporationBreinigsville, PA, United States
    serp_jobs.job_card.full_time
    We are currently hiring a Continuous Improvement Manager in our Breinigsville, PA brewery.Boston Beer Company is in a period of rapid growth, and we need to develop our manufacturing capability to ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    PT Associate Center Store Replenishment - 6320

    PT Associate Center Store Replenishment - 6320

    The GIANT CompanyLehighton, PA, United States
    serp_jobs.job_card.full_time
    USA-PA-Lehighton-1241 Blakeslee Boulevard.At The GIANT Company we're committed to making our stores and facilities better every day for our team members, customers, and communities.It's our secret ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Execution Specialist

    Execution Specialist

    ReeledgeLanghorne Manor, PA, US
    serp_jobs.job_card.full_time
    Candidates for this work-from-home position must be 21 or older, have an SSN, own a.Pennsylvania, Michigan and West Virginia. We are a gambling technology company seeking talented and motivated indi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Lead Engineer

    Lead Engineer

    Chesapeake Utilities CorporationPocono Lake, PA, United States
    serp_jobs.job_card.full_time
    Remote Within Service Territory -.DE, PA, OH, GA, NC, VA, MD or FL).The Lead Engineer plays a pivotal role in training and process improvement, developing and leading training programs for the Engi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Focus Group

    Focus Group

    ReeledgeDelaware Water Gap, PA, US
    serp_jobs.job_card.full_time +1
    Candidates for this work-from-home position must be 21 or older, have an SSN, own a.Pennsylvania, Michigan and West Virginia. We are a gambling technology company launching a new service and looking...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    PT Associate Center Store Replenishment - 6486

    PT Associate Center Store Replenishment - 6486

    The GIANT CompanyKutztown, PA, United States
    serp_jobs.job_card.full_time
    USA-PA-Kutztown-15100 Kutztown Road.At The GIANT Company we're committed to making our stores and facilities better every day for our team members, customers, and communities.It's our secret recipe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Quality Assurance Associate

    Quality Assurance Associate

    AdvatixBreinigsville, PA, US
    serp_jobs.job_card.full_time
    Quality Assurance And Regulatory Compliance Associate.The QARC Associate oversees all Quality Assurance activities for their assigned Distribution Center. This position serves as an interface for th...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Data Quality Specialist

    Data Quality Specialist

    Northampton Community CollegeBethlehem, PA, United States
    serp_jobs.job_card.full_time
    The staff and faculty of Northampton Community College share a single goal : to help students transform their lives through education. It's a goal that reaps rewards thousands of times over the cours...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Validation Field Specialist

    Validation Field Specialist

    Ecolab Inc.Horsham, PA, US
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Quality Assurance Analyst - Access Center

    Quality Assurance Analyst - Access Center

    St. Luke's University Health NetworkAllentown, PA, US
    serp_jobs.job_card.full_time
    Luke's is proud of the skills, experience and compassion of its employees.Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Quality Control Inspector I - 3rd Shift

    Quality Control Inspector I - 3rd Shift

    B Braun MedicalAllentown, PA, United States
    serp_jobs.job_card.full_time
    Braun US Device Manufacturing LLC.Allentown, Pennsylvania, United States.Friday, Thursday, Wednesday, Tuesday, Monday.Other key product areas include nutrition, pharmacy admixture and compounding, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Data Integrity and eCompliance

    Data Integrity and eCompliance

    Germer International - Pharmaceutical RecruitingAllentown, PA, US
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days