Quality Assurance Senior Associate I

3 days ago


Wilmington, Ohio, United States Alkermes Full time
Job Summary

The Quality Assurance Senior Associate is responsible for supporting daily operations and monitoring compliance of the Oral Solid Dose (OSD) Manufacturing Area at Alkermes.

Main Responsibilities
  • Act as QA OSD Support representative on special committees and teams.
  • Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements.
  • Actively participate and contribute to the QA mission and objectives.
  • Deliver key business messages to superiors and/or peers in a timely manner.
  • Develop metrics and other tools to measure QA OSD Support and/or systems.
  • Understand departmental KPIs and their impact on site targets.
Key Activities
  • Interact with OSD Manufacturing personnel to ensure cGMP compliance and provide general guidance and support.
  • Review and approve SOPs, master production records, training plans, work orders, and controlled forms.
  • Provide input for, review, and approval of technical protocols and reports, equipment, process, and cleaning documents authored by the validation.
  • Review, approve, and oversee the change control process for minor change controls generated by the OSD Manufacturing Area, including amendments and extensions.
  • Act as the QA Contact and QA Approver for OSD Manufacturing investigations, incidents, minor deviations, environmental excursions, and executed CAPA.
Qualifications
  • Capable of identifying solutions and following through to implementation.
  • Has the capacity to monitor the effectiveness of system and process changes and continuously improve.
  • Excellent communication and documentation skills.
  • Demonstrates empathy and active listening and provides opportunities for individuals to talk freely in an open honest discussion setting.
  • Communicates well in team settings.
  • Seeks to understand others with diverse view points and expertise.
  • Builds strong relationships with stakeholders external to QA and takes advantage of these relationships to identify new opportunities.
Requirements
  • Experience providing feedback on deficiencies to improve systems, procedures, and training.
  • Demonstrates diplomacy and tact to diffuse tense situations and presents facts to support decision/point of view.
  • Possesses the skills necessary to provide effective training/mentorship.
  • Familiarization with oral solid dose manufacturing qualification and quality.
  • Possesses a good understanding of current quality control and quality assurance GMP regulations.
  • Continues to develop knowledge in OSD and expands breadth of knowledge to include areas outside of direct function.
  • Possesses the drive to achieve results and proactively seeks solutions when circumstances and goals are challenging, taking action to overcome likely obstacles.
  • Demonstrates ability to generate and critique high quality/quantity of results from the QA team and present them coherently to an internal and/or external audience.


  • Wilmington, Ohio, United States Alkermes Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Associate to join our team at Alkermes. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with internal procedures, policies, and standards, as well as all relevant State, Federal, and International regulations.Key ResponsibilitiesEnsure...


  • Wilmington, Ohio, United States Hood Packaging Full time

    Job SummaryHood Packaging Corporation is a leading manufacturer of packaging materials, committed to providing high-quality products in a safe and efficient environment. We are seeking a skilled Quality Technician to join our team in Wilmington, OH.Key ResponsibilitiesConduct material testing and process inspections to ensure compliance with established...


  • Wilmington, Ohio, United States Alkermes Full time

    About the RoleWe are seeking a highly skilled Quality Control Specialist to join our team at Alkermes. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our products.Key ResponsibilitiesSampling and Inspection: Conduct thorough sampling and inspection of incoming materials, including...


  • Wilmington, Ohio, United States Alkermes Full time

    About the RoleWe are seeking a highly skilled Quality Control Specialist to join our team at Alkermes. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our products.Key ResponsibilitiesSampling and Inspection: Conduct thorough sampling and inspection of incoming materials, including...


  • Wilmington, Ohio, United States Hood Packaging Full time

    Job SummaryHood Packaging Corporation is a leading manufacturer of packaging materials, committed to providing high-quality products and services to our customers. We are seeking a skilled Quality Technician to join our team in Wilmington, OH.Key ResponsibilitiesPerform material testing and process inspection to ensure compliance with established standards...

  • Production Associate

    10 hours ago


    Wilmington, Ohio, United States Trillium Staffing Full time

    Job Summary:We are seeking a skilled and detail-oriented Production Associate to join our team at Trillium Staffing. As a Production Associate, you will play a critical role in ensuring the quality and efficiency of our production process.Key Responsibilities:Remove finished products from the production line and pack them for shippingConduct basic quality...

  • Senior Auditor

    2 weeks ago


    Wilmington, Ohio, United States Air Transport Services Group Full time

    Position Overview:We are seeking a Senior Internal Auditor to enhance our auditing capabilities.Key Responsibilities:Report directly to the Corporate Compliance & Internal Audit Manager.Assist in the strategic planning and execution of audits, including Sarbanes Oxley (SOX) and non-SOX evaluations.Review the documentation and testing processes conducted by...

  • Senior Auditor

    2 weeks ago


    Wilmington, Ohio, United States Air Transport Services Group Full time

    Position Overview: The Senior Auditor will report directly to the Corporate Compliance & Internal Audit Manager, playing a crucial role in the planning and execution of audits, including both Sarbanes-Oxley (SOX) and non-SOX evaluations throughout the organization.Key Responsibilities:Oversee and review the work of Internal Auditors, ensuring thorough...

  • Retail Associate

    2 weeks ago


    Wilmington, Ohio, United States Listedbuy Full time

    Position Title: Retail AssociateCompany: ListedbuyOverview: The primary role of a Retail Associate is to deliver exceptional service to every customer by adhering to the company's service standards. This position involves ensuring the store operates smoothly and efficiently while maintaining a high level of integrity and compliance with all regulations.Key...


  • Wilmington, Ohio, United States The AZEK Company Full time

    Job Title: Production AssociateCompany: The AZEK CompanySalary: $16 - $18.50 per hour with 10% Shift Differential for Night ShiftKey Responsibilities:Ensure safe operations and adhere to health, safety, environmental, and quality standards.Support the production of high-quality products in accordance with specifications.Conduct quality assessments to verify...


  • Wilmington, Ohio, United States Alkermes, Inc. Full time

    Job SummaryThe Associate Director, Process Development position at Alkermes, Inc. leads process development activities at our Wilmington facility, providing technical guidance for small molecule process development, scale-up, and technical transfer to manufacturing.Key ResponsibilitiesProvide subject matter expertise in process development methodologies,...


  • Wilmington, Ohio, United States Alkermes, Inc. Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Manufacturing Associate to join our team at Alkermes, Inc. in a Bulk Production role.Key ResponsibilitiesOperate and Maintain Equipment: Perform all necessary operation activities in bulk manufacturing, including equipment cleaning, setup, operation, and batch processing.Follow Standard...


  • Wilmington, Ohio, United States Fifth Third Full time

    About the RoleFifth Third Bank is seeking a highly motivated and customer-focused individual to join our team as a Retail Personal Banker I. As a key member of our Financial Center team, you will play a critical role in delivering exceptional customer experiences and driving business growth.Key ResponsibilitiesCustomer Engagement: Build strong relationships...


  • Wilmington, Ohio, United States Fifth Third Full time

    Transforming Banking ExperiencesWe're seeking a talented individual to join our team as a Retail Personal Banker I. As a key member of our Financial Center, you'll play a crucial role in delivering exceptional customer experiences and driving business growth.Key Responsibilities:Customer Engagement: Build strong relationships with customers, understand their...


  • Wilmington, Ohio, United States ABX Air Full time

    The Aviation Ground Operations Trainer and Auditor specializes in the loading of aircraft cargo and is responsible for conducting SMS Safety Assurance audits and Safety Risk Management of ground operations procedures and services delivered by airline personnel and contractors. This role involves effective communication and coordination regarding technical,...


  • Wilmington, Ohio, United States LAUNCH Technical Workforce Solutions Full time

    Role Overview: As an Avionics Systems Specialist, you will be responsible for the integration and modification of various avionics systems within aircraft.Key Responsibilities:1. **Installation** of critical components such as APU ECU, APU hour meter, Communication Panel, Cockpit Voice Recorder (CVR), Emergency Locator Transmitter (ELT) relocation, and Dual...


  • Wilmington, Ohio, United States Compass Group Careers Full time

    Position OverviewCompass Group is seeking a dedicated Lead Dietitian to enhance our nutrition team within a prominent healthcare facility.Key Responsibilities:Deliver comprehensive medical nutrition therapy, including assessments, dietary modifications, and patient education.Ensure compliance with all relevant regulatory standards and guidelines.Maintain...

  • Project Manager

    3 days ago


    Wilmington, Ohio, United States Jobot Full time

    About the RoleWe are seeking a highly skilled and experienced Project Manager to lead our engineering team in the development and implementation of new battery management systems. As a key member of our team, you will be responsible for ensuring the quality and reliability of our products, as well as managing supplier relationships and ensuring compliance...


  • Wilmington, Ohio, United States Alkermes Full time

    Job OverviewPosition Summary:The Process Development Manager oversees the initiatives related to the development, scaling, and technical transition of small molecule oral solid dosage forms to the production facility. The ideal candidate will excel in a collaborative team environment, facilitating key decision-making processes to ensure the effective...


  • Wilmington, Ohio, United States Buffalo Wild Wings Full time

    JOB PURPOSE: The main objective of this position is to deliver an outstanding and tailored experience for guests at Buffalo Wild Wings by offering food and drink selections in a welcoming and knowledgeable manner.Engage with guests in meaningful discussions to build loyaltyParticipate in evaluation programs to enhance service qualityFollow company protocols...