The job below is no longer available.
You might also like
in Philadelphia, PA
$13est. per hour Loews Hotels, LLC • 7h agoUrgently hiring 3.5 mi Use left and right arrow keys to navigate- $41
est. per hour St. Mary Rehabilitation Hospital • 14h agoJust posted Urgently hiring 17.1 mi Use left and right arrow keys to navigate - $47
est. per hour Diversified Protection Corporation • 7h agoUrgently hiring 7.6 mi Use left and right arrow keys to navigate - $57
est. per hour CSL Behring • 14h agoUrgently hiring 15 mi Use left and right arrow keys to navigate - CSL Behring • 14h ago
Urgently hiring 15 mi Use left and right arrow keys to navigate
Quality Assurance
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Philadelphia, PA Philadelphia, Pennsylvania |
About this job
Position Summary: Reviews Testing batch records in accordance with cGMP and GLP for Nonclinical Laboratory Studies, as applicable. Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner.
- Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
- Maintains awareness of activities by routine direct observation of testing laboratories. Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management.
- Compiles and reviews Testing batch records in accordance to cGxP and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
- Compiles and reviews raw data, batch records and test results, including Final Reports and CoAs, in accordance with cGMP, cGLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
- Reviews and approves Non-conforming events (NCE) and Laboratory Investigation Reports (LIR).
- Write and revise SOPs as necessary.
- Reviews and approves document change requests.
- Performs Equipment Validation review and approval.
- Perform timely review of complex study files, such as: Assay Validations, Qualifications, Viral Clearance.
- Perform QA inspections including, but not limited to GLP studies.
Position Requirements:
- Must have a��BA/BS degree in a Science related major
- Must have at least��2+ years of experience in QA
- Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
- Ability to record data accurately and legibly.
- Experience with CAPA
About Aerotek:
Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .
Aerotek is acting as an Employment Agency in relation to this vacancy.
Your Privacy Choices