Temp-QC Associate

4 weeks ago

Wilmington, Delaware, United States Alkermes, Inc. Full time

QC ASSOCIATE I

The QC Associate I is responsible for sampling and inspecting various incoming materials including but not limited to raw materials active pharmaceutical ingredients, excipients, components, and processing aids. The QC Associate I interacts with multiple departments such as Quality Assurance, Manufacturing, Receiving and Supply Chain. He/she is responsible for evaluating information and products and reporting any discrepancies or defects.

MAJOR RESPONSIBILITIES:

  • Follow written procedures
  • Review documentation such as CofAs, assign expiration and retest dates for incoming raw materials
  • Coordinate the sampling of all incoming raw materials and components
  • Collaborate with Supply Chain, Warehouse, Receiving, Quality Assurance, Operations and the testing laboratory in order to schedule activities.
  • Log samples into Laboratory Information Management System (LIMS), assign testing requirements and enter analytical results
  • Verify raw material labeling such as part and lot numbers
  • Inspect containers for defects and damage
  • Clean sampling equipment and any associated sampling areas
  • Operation of equipment such as glove-boxes, fume hoods, bio safety cabinets and balances
  • Perform sampling for all raw materials, active ingredients, excipients, components, processing aids etc
  • Follow written procedures for sampling techniques and requirements.
  • Perform the visually inspection and dimensional testing of components
  • Operation of equipment such as calipers, tape measure, gauge blocks and sight gauges
  • Identify non-conforming materials at any point in the process
  • Coordinate retain program
  • Prepare and maintain retain samples for raw materials
  • Receive and maintain finished product retain samples
  • Plan, schedule and execute periodic retain inspections in compliance with written procedures for both raw materials and finished products
  • Perform disposals of both raw materials and finished products when appropriate
  • Author and review Standard Operating Procedures, technical reports, specifications, as required
  • Train other colleagues in methods and procedures.
  • Assist in investigating any non-conformances or problems noted during the sampling/inspection process.
  • Use electronic document, inventory and maintenance systems
    • LIMS
    • SAP
    • Veeva
    • Microsoft Word
    • Microsoft Excel
    • Maximo

EDUCATION AND EXPERIENCE:

Associate's degree or equivalent experience required; Bachelor's degree in a scientific discipline preferred.

A minimum of 1 year experience in a pharmaceutical or other regulated industry preferred.

PREFERRED QUALIFICATIONS:

  • Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts.
  • Ability to handle multiple projects with competing priorities.
  • Fundamental understanding of mathematics.
  • Intermediate skills in computer use with ability to learn and master new computer applications.
  • Self-directed and motivated, detail oriented, quality minded with strong organizational skills.
  • Effective oral and written communication skills
  • When required, interact with internal and external auditors.
  • Understands paperwork review process.
  • Ability to follow written procedures and exhibit excellent documentation practices.
  • Ability to take on additional tasks, as required.
  • Ability to lift up to 50lbs
  • Work well independently or with a group
PDN-9c09ae b39e-8ed0539f1577

  • Temp-Training Specialist

    4 weeks ago

    Wilmington, Delaware, United States Alkermes, Inc. Full time

    The TrainingCoordinator role providesstrong administrative support with some operational support forthe learning management system (LMS) and processes used for the management of compliance training at Alkermes.Key DutiesAdministration of the LMS, Docusign system and filing training documents.Manage day to day compliance training queries and reports.Interface...

  • Temp-Training Specialist

    2 months ago

    Wilmington, Delaware, United States Alkermes, Inc. Full time

    The TrainingCoordinator role providesstrong administrative support with some operational support forthe learning management system (LMS) and processes used for the management of compliance training at Alkermes.Key DutiesAdministration of the LMS, Docusign system and filing training documents.Manage day to day compliance training queries and reports.Interface...

  • Quality Technician

    2 weeks ago

    Wilmington, Delaware, United States Synerfac Technical Staffing Full time

    Job DescriptionJob DescriptionSchedule: WEEK 1: Mon, Tue, Fri, Sat, Sun 7AM-7PMWEEK 2: Wednesday, Thursday 7AM-7PMWEEK 3: MondayFriday 7AM-3PMWEEK 4: Mon, Tue, Fri, Sat, Sun 7PM-7AM*Rotation starts over after Week 4*Overview:The Quality Control Lab Technician supports Manufacturing and various departments on site with analytical testing. The Quality...

  • Physician / Hospitalist / Ohio / Locum or Permanent / Hospitalist needed in Wilmington, OH Job

    4 days ago

    Wilmington, Delaware, United States Cross Country Locums Full time

    Cross Country Locums is seeking a Board-Certified Hospitalist for an amazing opportunity in Wilmington, OH.Please see the job description below:Work Dates Needed: Sun -Sat Preferred Schedule: 7a -7p, 7p -7a; 7 on/7 off shift Procedures Required Licenses, Certifications, Requirements: BC/BE IM orFP EMR: MedHostIf you are interested in this great opportunity,...

  • Accounts Payable/Receivable Clerk

    4 weeks ago

    Wilmington, Delaware, United States PrideStaff Full time

    Accounts Receivable/Payable ClerkCompanies in the area are searching for experienced, proven individuals for temporary and temp-to-hire assignments to hit the ground running and contribute right away. Come join PrideStaff to put your talents and skills to work. PrideStaff has been working for over thirty-five years across the country in filling the needs for...

  • Accounts Payable/Receivable Clerk

    2 months ago

    Wilmington, Delaware, United States PrideStaff Full time

    Accounts Receivable/Payable ClerkCompanies in the area are searching for experienced, proven individuals for temporary and temp-to-hire assignments to hit the ground running and contribute right away. Come join PrideStaff to put your talents and skills to work. PrideStaff has been working for over thirty-five years across the country in filling the needs for...

  • Assoc Scientist

    4 weeks ago

    Wilmington, Delaware, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsCleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors...

  • Assoc Scientist

    1 month ago

    Wilmington, Delaware, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsCleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors...

  • Sales Associate

    3 weeks ago

    Wilmington, United States Spencer Gifts Full time

    Employee Type: Seasonal/Temp Location: Wilmington Job Type: Other Experience: Not Specified Date Posted: 5/31/2024 Job Description Brand - Spirit Halloween The Sales Associate will support the Store Management Team in the setup, merchandising, pack-up and teardown of a seasonal store. The Sales Associate is responsible for maintaining Guest Services as per...

  • Sales Associate

    2 days ago

    Wilmington, United States Spencer Gifts Full time

    Employee Type: Seasonal/Temp Location: Wilmington, DE Job Type: Other Experience: Not Specified Date Posted: 6/7/2024 Job Description Brand - Spirit Halloween The Sales Associate will support the Store Management Team in the setup, merchandising, pack-up and teardown of a seasonal store. The Sales Associate is responsible for maintaining Guest Services as...

  • Manufacturing Quality Assurance Associate

    3 weeks ago

    Wilmington, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...

  • Manufacturing Quality Assurance Associate

    4 weeks ago

    Wilmington, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor s degree or higher in a scientific or engineering discipline...

  • Manufacturing Quality Assurance Associate

    4 weeks ago

    Wilmington, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor s degree or higher in a scientific or engineering discipline...

  • Manufacturing Quality Assurance Associate

    3 weeks ago

    Wilmington, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor s degree or higher in a scientific or engineering discipline...

  • Manufacturing Quality Assurance Associate

    4 weeks ago

    Wilmington, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...

  • Manufacturing Quality Assurance Associate

    4 weeks ago

    Wilmington, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...

  • Manufacturing Quality Assurance Associate

    4 weeks ago

    Wilmington, United States Quality Chemical Laboratories Full time

    Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...

  • Warehouse Associate

    2 weeks ago

    Wilmington, United States The DAVIS Companies Full time

    Job DescriptionJob DescriptionWarehouse Associate - $20/HR If you want to work with a progressive company, this is just what you have been waiting for! Leading robotics company in Wilmington, MA has an immediate need for a Warehouse Associate. This is a temp to hire opportunity. Pay Rate of the Warehouse Associate: $20/hrResponsibilities of the Warehouse...

  • Warehouse Associate

    2 months ago

    Wilmington, United States Kelly Services Full time

    Job DescriptionJob DescriptionKelly® Professional & Industrial will help put your career in motion with this great, new opportunity. Our prominent company in Wilmington NC is in partnership with Kelly to find a Warehouse Associate to join the team. Sound intriguing? Read on to learn more and apply!Schedule and Pay:Shift: 8am-5pm (Monday-Friday)  Only...

  • Warehouse Associate

    4 weeks ago

    Wilmington, United States Kelly Services Full time

    Job DescriptionJob DescriptionKelly® Professional & Industrial will help put your career in motion with this great, new opportunity. Our prominent company in Wilmington NC is in partnership with Kelly to find a Warehouse Associate to join the team. Sound intriguing? Read on to learn more and apply!Schedule and Pay:Shift: 8am-5pm (Monday-Friday)  Only...

  • Associate Scientist

    2 weeks ago

    Wilmington, United States Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are...

  • Production Associate

    6 days ago

    Wilmington, United States Atlantic Staffing Consultants Full time

    We have an immediate opening for a Warehouse Production Associate off HWY 421 between Wilmington & Leland! Weekly Pay! Apply now and get in with an awesome local company who promotes from within as a Warehouse Production Associate. Essential duties and responsibilities of the Warehouse Production Associate:Assist shipping and receiving unloading and...

  • client services associate

    3 weeks ago

    Wilmington, United States Randstad Full time

    client services associate. wilmington , delaware posted 8 days ago job details summary $25 - $35 per hour temp to perm bachelor degree category business and financial operations occupations referenceAB_4547216 job details Randstad is partnering with one of our national clients in the Financial Services industry, and recruiting candidates to join...

  • Temp-Visual Inspector

    2 months ago

    Wilmington, United States Alkermes Full time

    This is a temporary position. GENERAL DESCRIPTION: To inspect the GMP (Good Manufacturing Practices) product within container (vials/ syringes) for defects. Perform label and packaging activities for finished product. KEY DUTIES: * Inspect finished product and empty containers for defects * Perform daily process activities in compliance with standard...

  • Temp-Visual Inspector

    4 weeks ago

    Wilmington, United States Alkermes Full time

    This is a temporary position. GENERAL DESCRIPTION: To inspect the GMP (Good Manufacturing Practices) product within container (vials/ syringes) for defects. Perform label and packaging activities for finished product. KEY DUTIES: * Inspect finished product and empty containers for defects * Perform daily process activities in compliance with standard...

  • Temp-Visual Inspector

    2 weeks ago

    Wilmington, United States Alkermes Full time

    This is a temporary position. GENERAL DESCRIPTION: To inspect the GMP (Good Manufacturing Practices) product within container (vials/ syringes) for defects. Perform label and packaging activities for finished product. KEY DUTIES: Inspect finished product and empty containers for defects Perform daily process activities in compliance with...

  • Temp-Training Specialist

    2 months ago

    Wilmington, United States Alkermes Full time

    The Training Coordinator role provides strong administrative support with some operational support for the learning management system (LMS) and processes used for the management of compliance training at Alkermes. Key Duties • Administration of the LMS, Docusign system and filing training documents. • Manage day to day compliance training...

  • Temp-Visual Inspector

    2 weeks ago

    Wilmington, United States Alkermes Full time

    Job DescriptionThis is a temporary position.GENERAL DESCRIPTION: To inspect the GMP (Good Manufacturing Practices) product within container (vials/ syringes) for defects. Perform label and packaging activities for finished product. KEY DUTIES: Inspect finished product and empty containers for defects Perform daily process activities in compliance with...