GMP Training Specialist at Piney Scientific

The Training, Tracking & Trending Specialist is responsible for training, tracking and trending of cGMP and compliance activities, including Annual Product Reviews (APRs), monthly, quarterly, and annual trending reports, and trending support of deviations, investigations and CAPA effectiveness.   

Duties /Responsibilities

Trains new employees on tracking and trending compliance and reviews training documentation for accuracy

Performs Annual Product Reviews for all commercial products

Tracks and trends miscellaneous cGMP Data for Production, QA, QC, Validation, etc.

Conducts monthly, quarterly, and annual trending reports

Utilize electronic training system to facilitate compliance to training program of site personnel

Applies principles outlined in CFR, ICH, and FDA guidelines

Assist with FDA inspections as necessary and/or required

Follows requirements of batch records, SOPs, test methods, validation protocols, validation reports, calibration, and change control records to administer quality and compliance into processes

Coordinates with other departments about recent trends and reporting

Minimum Qualifications

Bachelor’s Degree in Pharmacology, Pharmaceutics, Science or related field with 2-4 years’ experience in pharmaceutical or biotech industry or equivalent combination of education and experience required.  Master’s degree preferred.

Duties: The basic purpose of this position is to perform sampling, inspection, and documentation review of starting materials through finished goods for biological and pharmaceutical products.  This position assures that all work is performed at a high level of accuracy, quality and that specifications are met prior to release according to all internal, Corporate and regulatory requirements (USDA, FDA, EU, etc).

Holds quality and reliability as high standards of production and service for own work.Follows established quality assurance procedures and learns how factors outside of own work area may impact processes and tasks within own work area.

Skills: Good written communication skills, including attention to detail, ability to follow written procedures, SOPs, specifications and other documents, and ability to perform basic mathematical calculations are required.

Skills and Experience:

Required Skills: 

FDA

LIFE SCIENCES

QA

QUALITY ASSURANCE

SOPS

Additional Skills:

DOCUMENTATION

Bachelor’s Degree in Pharmacology, Pharmaceutics, Science or related field with 2-4 years’ experience in pharmaceutical or biotech industry or equivalent combination of education and experience required.  Master’s degree preferred.

Holds quality and reliability as high standards of production and service for own work.Follows established quality assurance procedures and learns how factors outside of own work area may impact processes and tasks within own work area.

Skills: Good written communication skills, including attention to detail, ability to follow written procedures, SOPs, specifications and other documents, and ability to perform basic mathematical calculations are required.

FDA

LIFE SCIENCES

QA

QUALITY ASSURANCE

SOPS

Additional Skills:

DOCUMENTATION