Annual Product Records Review Associate

Company: LanceSoft Inc
Location: Rocky Mount
Posted on: August 8, 2022

Job Description:

Job Description: Repost 25736 - Please do not submit previously submitted candidates
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 sites
- Must be able to work and communicate effectively with all levels of people within the organization.
- Must be able to work and communicate effectively with all types of suppliers to help resolve issues

Education
Bachelors 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)
Position Comments visible to MSP and Supplier: Repost 25736 - Please do not submit previously submitted candidates

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)

Keywords: LanceSoft Inc, Rocky Mount , Annual Product Records Review Associate, Other , Rocky Mount, North Carolina