GMP Investigator Job at Insight Global, Malvern, PA

OGc5cDVHeDl0Y05hblZJNlphTnFDdzB6bmc9PQ==
  • Insight Global
  • Malvern, PA

Job Description

Requirements:

-Bachelor's degree in Scientific field

-Minimum 2 years of experience working in a GMP manufacturing environment

-Minimum 1 year of experience performing investigations

-Experience with technical writing and written investigations with appropriate grammar

-Experience with quality document reviews and regulatory inspection processes required

-Team player attitude

Preferred:

-Prior experience supporting deviations, root cause analysis and CAPA activities

-Cleanroom experience – gowning requirement, ISO standards

-Working knowledge of quality event management systems such as Trackwise and Investigation Tools such as pareto and Ishikawa analysis

-Experience with Quality Event Management Systems such as Trackwise, COMET, and other QEM applications/systems

-Familiarity with cell and gene therapy modalities

Job description:

Our large pharmaceutical client is currently seeking a GMP Investigator to join their growing Cell Banking team within their R&D group in Malvern, PA. As an Investigator, you will be responsible for independently supporting simple, moderate, and complex investigations to ensure product quality. You’ll be providing quality review of GMP documentation related to the support of QC and R&D, as well as Engineering activities by reviewing and approving protocols, reports, SOPs, and change controls for appropriateness, completeness, and alignment with quality, validation and regulatory expectations. You will also be reviewing and approving lab-related deviations and resulting investigation reports, corrective actions, and/or preventive actions.

Responsibilities will include:

- Opens and manages quality issues and investigations for GMP operations in Cell Banking.

- Performs various root-cause problem solving activities to determine underlying causes for quality issues and investigations.

- Performs identification of effective corrective and preventative actions.

- Initiates and Execute CAPAs & corrections as result of investigations.

- Support compliance initiatives within the manufacturing laboratory areas and within Cell Banking including, but not limited to: QRAs, Change Controls, Commitment Records, Test Records, Quality Issues, & Commitment Records.

Job Tags

Bank staff,

Similar Jobs

gpac

Pediatric Dentist Job at gpac

Job DescriptionAre you a compassionate and skilled Pediatric Dentist looking for an opportunity to make a positive impact on children's oral health? Join a dynamic team where we prioritize providing exceptional care in a supportive and family-friendly environment. Key... 

Barksdale Control Products

Product Management Intern Job at Barksdale Control Products

 ...1949, is a leading manufacturer of highly engineered control products. As a subsidiary of Crane Co., a $2B industrial conglomerate,...  ...analysis to support 80-20, pricing and other sustaining product management functions. KEY RESPONSIBILITIES These responsibilities... 

Progressive Maryland

Environmental Community Organizer Job at Progressive Maryland

 ...Job Description Job Description Community Organizer &##128205; Location: Maryland (Regional Assignment)&##128188; Reports to: Director of Organizing &##128231; Applications must include a cover letter explaining your interest in community organizing and working... 

Citizens Medical Center

Nurse Practitioner/Physician Assistant Nocturnist - (FT) Job at Citizens Medical Center

 ...includes an onsite medical helicopter. Citizens has a comprehensive Community Cancer Program that includes two linear accelerators and HDR brachytherapy. Citizens is recognized for its outstanding cardiology program which includes a nationally accredited Chest Pain Center... 

Sherwin-Williams

Print Operator Job at Sherwin-Williams

 ...The Print Operator is a hybrid role responsible for supporting print production and finishing at the Print Center. The ideal candidate will be responsible for setting up, adjusting, and operating various cut sheet and wide format printers. This position will process production...