Quality Assurance Specialist

6 days ago


Randolph, United States Spectrum Staffing ServicesHRStaffers Inc. Full time

SUMMARY

The Quality Assurance Complaints Specialist ensures manufacturing procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The position supports operational needs and activities in order to successfully achieve quality goals and complaints metrics.

RESPONSIBILITIES

  • Handles product complaints received from customer service department.
  • Initiates, process and send notifications as required by applicable Standard Operating Procedures (SOPs).
  • Interacts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint.
  • Evaluate complaints for regulatory reportability and create and submit reports that comply with applicable regulations.
  • Writes, investigates and ensures timely submission of complaints investigation.
  • Reviews and approves complaint investigation submitted by other team members.
  • Collaborates with other departments to ensure technical issues are being addressed and investigations are conducted thoroughly.
  • Initiates applicable Corrective Action/Preventative Action (CAPA) plans.
  • Accurately maintain product complaint logs (softcopy and hardcopy) through internal database tracking system and complete all filing and closing procedures as required by applicable Standard Operating Procedures (SOPs)
  • Responsible for ensuring that paperwork is complete for each complaint folders.
  • Perform other duties and assume responsibilities as appropriate or assigned.

QUALIFICATIONS

  • Bachelor’s degree required, preferably life sciences
  • 2+ years of experience in pharmacy operation or experience in cGMP environment
  • Must be able to facilitate collaboration, while knowing when to move to end analysis and recommend decisions
  • Strong written, verbal and presentation communication skills
  • Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) required
  • Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards

COMPENSATION: $25-$30/hr.



  • Randolph, New Jersey, United States Triman Industries Inc Full time

    Job OverviewWe are seeking a highly skilled Aerospace Quality Assurance Specialist to join our team at Triman Industries Inc. This is an exciting opportunity for individuals who are passionate about quality and want to make a difference in the aerospace industry.


  • Randolph, New Jersey, United States Triman Industries Inc Full time

    Job OverviewThe Mechanical Inspector role is an exciting opportunity to work with our team and contribute to the production of high-quality products. With a focus on quality assurance and control, you will play a vital role in maintaining the integrity of our products.


  • Randolph, New Jersey, United States Triman Industries Inc Full time

    About Triman Industries IncWe are a leading manufacturer in the aerospace industry, and we're seeking an experienced Quality Assurance Manager to join our team. As a key member of our quality department, you will be responsible for directing and implementing quality policies and procedures to ensure that our products meet the highest standards.Estimated...


  • Randolph, Massachusetts, United States K.A. Recruiting Full time

    This Point of Care Specialist opportunity in Randolph, Massachusetts offers an estimated salary of $65,000 - $85,000 per year. In this role, you will manage the point-of-care testing processes within the laboratory, ensuring quality control and regulatory compliance. Effective communication among healthcare staff is crucial for success.Job SummaryThe Point...


  • Randolph, New Jersey, United States Triman Industries Inc Full time

    About Triman Industries IncWe are a leading manufacturer in the aerospace industry, and we're seeking an experienced Senior Quality Control Specialist to join our team. As a key member of our quality department, you will be responsible for ensuring that our products meet the highest standards of quality.Estimated salary: $80,000 - $110,000 per year,...


  • Randolph, New Jersey, United States Triman Industries Inc Full time

    We are looking for a highly motivated Senior Quality Control Specialist to join our team at Triman Industries Inc. This role involves ensuring that quality control processes are implemented and maintained across the organization, with a focus on delivering high-quality products to our customers.The ideal candidate will have a bachelor's degree or equivalent...


  • Randolph, Vermont, United States ARA Full time

    Quality Assurance TechnicianAbout UsArcadia Research Associates (ARA) is a leader in providing innovative solutions to complex problems in the physical sciences. Our team of over 2,300 professionals across the United States and Canada offers a broad range of technical expertise in defense technologies, civil technologies, computer software and simulation,...


  • Randolph, Wisconsin, United States Regal Rexnord Corp Full time

    About the Job:We are seeking a highly skilled Mechanical Assembly Specialist to join our team at Regal Rexnord Corp.The successful candidate will be responsible for assembling and testing mechanical components, including structural assembly, mechanical drive assembly, and fluid control assembly. They will also be required to complete quality assurance checks...


  • Randolph, Massachusetts, United States K.A. Recruiting Full time

    Job Description: We are seeking a highly skilled Point of Care Specialist to join our team in Randolph, Massachusetts. As a Point of Care Specialist, you will be responsible for managing the point-of-care testing processes within the laboratory, ensuring quality control, regulatory compliance, and effective communication among healthcare...


  • Randolph, United States Select Medical Full time

    Ensures the highest level of customer service to patients, fellow employees, and referrals sources through the coordination and administration of facility's "front office" activities. Assures provision of office functions such as patient scheduling, Patient, Specialist, Service, Customer Service, Healthcare


  • Randolph, Vermont, United States Applied Research Associates Full time

    Are you looking for a challenging opportunity to utilize your passion for quality in a technologically diverse field? At Applied Research Associates' Randolph, Vermont location, we develop some of the world's most innovative systems and technology.About the PositionThis role requires strong technical skills, with attention to detail and the ability to work...


  • Randolph, Massachusetts, United States Cortland Dental & Braces - a Benevis company Full time

    Job OverviewCortland Dental & Braces - a Benevis company is seeking a skilled Dental Hygiene Specialist to join their team. This role involves delivering high-quality dental care and services to patients under the supervision of a dentist.


  • Randolph, Massachusetts, United States Comfort Keepers - South Shore, Cape & Islands, MA Full time

    **Job Title:** Home Health Care SpecialistOverviewComfort Keepers, a leading provider of in-home care services, is seeking a dedicated and compassionate Home Health Care Specialist to join our team in South Shore, Cape & Islands, MA. As a key member of our team, you will play a vital role in delivering high-quality care to seniors in their...

  • Educatory Specialist

    3 weeks ago


    Randolph, Massachusetts, United States Soliant Full time

    Job OverviewSoliant, a leading healthcare staffing agency, is seeking an Educatory Specialist to join their team in Randolph, Massachusetts.Estimated Salary:$85,000 - $110,000 per year, depending on experience.Job DescriptionThis is an excellent opportunity for a skilled Speech-Language Pathologist to make a positive impact on the lives of students. As an...

  • Nurse Care Specialist

    4 weeks ago


    Randolph, Massachusetts, United States Mass General Brigham Full time

    About the Role:We are seeking a skilled Nurse Care Specialist to join our team at Mass General Brigham Healthcare at Home. As a Nurse Care Specialist, you will be responsible for providing high-quality, clinical services to patients in various settings within the community.Key Responsibilities:Deliver patient care within organizational philosophy, policy,...


  • Randolph, Massachusetts, United States CVS Health Full time

    About the RoleThe Staff Pharmacist plays a critical role in leading and directing Pharmacy Technician Support Staff, while overseeing the operation of all aspects within the pharmacy. This includes patient safety, professional practice, regulatory requirements, quality assurance, customer service, personnel management, inventory management, financial...


  • Randolph, New Jersey, United States Professional Physical Therapy Full time

    About UsAt Professional Physical Therapy, our mission is to provide the highest quality care to our patients. We are dedicated to helping them recover from injuries, regain mobility, and improve their overall quality of life.Salary and BenefitsThe estimated salary for this role is $45,000 - $55,000 per year, depending on experience and qualifications. Our...


  • Randolph, Massachusetts, United States Vinfen Corporation Full time

    About the Role:Vinfen Corporation seeks a dedicated Nighttime Support Specialist to join our team. As a member of our residential care staff, you will work directly with individuals who have intellectual and developmental disabilities in a small group setting or individual living arrangement.Key Responsibilities:Provide support and assistance to residents in...


  • Randolph, Massachusetts, United States Mass General Brigham Full time

    We are seeking a skilled Nursing Care Specialist to deliver high-quality patient care within the community. This role will involve providing clinical services in various settings, aligning with organizational philosophy and community health standards.About the PositionThis position requires a graduate of an approved School of Nursing with a current...


  • Randolph, Massachusetts, United States Cardinal of Minnesota, Ltd. Full time

    About the Role:We are seeking a highly motivated and compassionate Caregiver Support Specialist to join our team at Cardinal of Minnesota, Ltd. As a key member of our residential support services, you will play a vital role in ensuring the daily needs of our clients with intellectual and developmental disabilities are met.Salary and Benefits:The estimated...