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Engineering – Quality Engineer

  • Permanent
  • Anywhere

Website Pioneer Data Systems

Pioneer Data Systems

Company : Pioneer Data Systems

Country: United States

Location : Rocky Mount, North Carolina

Post: Sat, 10 Sep 2022 03:23:45 GMT

Expires: Sat, 08 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Position Details:

Our client, a world-leading Pharmaceutical Company in Rocky Mount, NC is currently looking for a Quality Associate to join their expanding team.

Job Title: Quality Associate / Pharma Manufacturing

Duration: 18 months contract, extendable up to 36 Months

Location: Rocky Mount, NC

Note:

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the company group medical insurance plan

Job Description:

The Annual Product Record Review Associate is responsible for writing Annual Product Record Review (APRR) reports according to pre-approved calendar, company procedures and our Quality Agreements.

The job duties include, but are not limited, to the following:

Establish the product matrix and the APRR calendar

Gather the required data and write APRR reports according to the calendar

Analyze trends, make recommendations based on the data in order to improve processes or tools

Send approved reports to clients according to applicable Quality Agreements

Must be able to work and communicate effectively with all levels of people within the other Pharmaceutical sites

Must be able to work and communicate effectively with all levels of people within the Pharmaceutical organization.

Must be able to work and communicate effectively with all types of suppliers to help resolve issues

Education

Bachelor’s Degree with 2+ years working in a GMP FDA regulated environment

Minimum of 1 years of experience in one or more of the following:

Quality Engineering/Compliance/Regulatory Affairs

Manufacturing/Technical experience in Pharmaceutical or GxP regulated environment

Technical Skills

Strong analytical skills and ability to summaries vast amounts of data

Capacity to manage several projects at a time

Knowledge of the local & international regulatory requirements and Quality Management standards & systems

Strong organizational, presentation, meeting facilitation and technical writing skills.

Possess attention to detail and good communication skills as verbal and written feedback to departments is required when issues are discovered during auditing.

Strong computer proficiency skills in MS Office, Word, Excel, Project, Trackwise (ER / LIR), and Empower LIMS System or equivalent.

ASQ Certification preferred.

Physical Position Requirements

Ability to work extended hours, especially during health authority inspections, assessments and audits.

Allow for flexibility in shifts to accommodate ad-hoc assignments on an as needed basis

Hybrid (Will need to Adhere to RETURN TO SITE POLICY)

Hard Skills:

Strong analytical skills and ability to summaries vast amounts of data

Capacity to manage several projects at a time

Communication (Verbal/Written)

Strong computer proficiency skills in MS Office, Word, Excel, Project, Trackwise (ER / LIR), and Empower LIMS System or equivalent.

Work Independently

Scientific Background

Soft Skills:

Team Environment (previously worked/works well in)

Meet aggressive timelines (provide examples of)

Adaptable to new challenges (Prioritize)

Interview:

1st – Phone Screen

2nd – WebEx

Hybrid (Will need to Adhere to RETURN TO SITE POLICY)

Minimum Education:

BS

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