|Reference # : ||18-08291
||Title : ||Excellent job opportunity of Quality Assurance Associate I|
|Experience Level : ||
||Start Date / End Date : ||01/30/2018 / 12/30/2019
| Description |
|Job Title: Quality Assurance Associate I|
Location: Swiftwater, PA
Duration: 11 months
Clinet : A Big Pharmaceutical Client
Prepare and Quality Review of Lot Release Protocol (LRP)
Quality Review of Batch Records
- Prepare and Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority.
- For licensed international pAroducts- ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country.
- Ensure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity.
Preparation & Certification of Working Documents
- Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA's 21 CFR, and other applicable health authority regulations.
- Complete all required system transactions associated with the batch record review process.
- Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material.
Compliance and Performance
- Prepare batch records from master documents in the electronic document management system according to procedure
- Ensure right first time preparation and completion of required documentation via electronic system (SAP and/or TrackWise)
- Provide support as required to ensure records are prepared and certified in accordance to the production planning schedule.
- Certified prepared batch records to ensure completeness and accuracy in accordance to procedure.
- Provide metrics in support of +QDCI board meetings.
- Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities.
- Investigate deviations, as assigned.
- Perform special projects as assigned by PQ Deputy Director.
- Team member of assigned project team(s). This includes, but is not limited to, review and approval of project related requirement documents, IS Change Requests, LabWare MDM forms, protocols, reports, user and functional specifications, etc.
- Excellent analytical, communication, interpersonal skills, as well as strong organizational and teamwork abilities.
- Knowledge of cGMP (US, Canada, Japan, Europe).
- Experience in SAP, Documentum, LIMS, and TrackWise is highly preferred.
Minimum Bachelor degree, preferably in Science or Life Sciences, with at least 1-2 years in a cGMP controlled/ pharmaceutical industry, preferably in a regulated Quality environment.
Interested candidates can share their most updated resume at firstname.lastname@example.org or reach out to me at 973-295-4583