Quality Assurance Specialist

  • location: Albany, GA
  • type: Contract
  • salary: $24.14 - $28.24 per hour
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job description

Quality Assurance Specialist

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now!

 
location: Albany, Georgia
job type: Contract
salary: $24.14 - 28.24 per hour
work hours: 9 to 5
education: Associate
 
responsibilities:
Job Responsibilities

  • Responsible for processing complaints to ensure quality and compliance with all SOPs, cGMP, company policies as well as FDA and other government and safety regulations by performing the following duties.
  • The primary responsibilities will be to complete complaint reports per the complaint governing site procedures.
  • The QA specialist will be responsible for processing and closing complaints in a timely manner.
  • Approves the complaint reports per the site procedure.
  • Initiates incidents in the investigation system per site procedures as required, i.e. if the complaint has a manufacturing root cause.
  • Additional responsibilities my include write or assisting with manufacturing investigation when required.
  • Work with the QA manager to resolve issues associated with complaints or the complaint system.
  • Duties:

    - Process and close complaints investigation reports in a timely manner.

    - Initiates incidents in the investigation system per site procedures

    - Approves the complaint reports per the site procedure

    - Interprets generated data and communicate results to Quality management. Maintain effective communication and partnership with Operations department.

    - Interacts with production, technical services, engineering, QC as part of the investigation process
 
qualifications:
Education & Qualifications

  • Bachelors Degree Required in sciences, chemistry, biology or engineering preferred (0-3 years experience)

    OR
  • Associates Degree accepted with 2+ years experience in Pharmaceutical/Medical Device
Essential Skills

- Three years related QA experience in a manufacturing environment.

- Strong understanding of cGMP concepts and requirements.

- Must be able to read, write, speak, and understand fluent English. Basic fundamental understanding of mathematics.

- Intermediate knowledge of MS Office.

- Able to demonstrate accuracy and thoroughness while completing work in a timely manner. Follows instructions, policies, and procedures.

Non-Essential Skills:

-Able to speak effectively before small to moderate sized groups.

Physical Demands:

-While performing the duties of this job, the employee is regularly required to sit in position for long times, minimum lifting is required.

 
skills: SOP, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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