Data Integrity Specialist

summary

Responsible for oversight of all data reliability matters for multiple sites. Perform data reliability related review of cGMP documents for Operations and Quality Control and assist the site in the closure of data reliability related discrepancies. Ensure entire site personnel are trained on data reliability requirements and compliance.

essential Duties and Responsibilities

• Review paper and electronic documents related to cGMP activities for verifying the compliance against data reliability requirements.
• Responsible for the oversight of cGMP areas and for verifying the compliance against data reliability requirements.
• Identify and document discrepancies by following applicable procedures.
• Communicate discrepancies to responsible personnel at the site to ensure compliance.
• Assist the respective site personnel to ensure compliance of data reliability related to observations.
• Identify areas where data reliability training is needed and provide appropriate training as required to the site personnel.
• Prepare data reliability documents for Operations and Quality Control.
• Maintain documentation related to data reliability review.
• Improve self-awareness and site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.

KNOWLEDGE/SKILLS/ABILITIES

• Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices(cGMP), FDA, DEA and other legislation regulating the production operation.
• PC proficiency using Microsoft Office required; Trackwise experience preferred.
• Outstanding oral communication and conflict resolution skills with all levels of the organization.
• Ability to think critically and apply critical thinking processes to data reliability investigations.
• Highly organized and able to work comfortably with accelerated work pace.

EDUCATION/EXPERIENCE

• Bachelor's degree in the sciences or related technical field.
• Five years' experience in a Quality role that involves conducting investigations, CAPA processes, managing Change Control programs, in-process checks in a pharmaceutical or other highly regulated environment such as medical devices.
• A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements.  

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

• Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
• Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
• Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull or otherwise move objects.

 The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
4. Individual may be required to wear respiratory devices that include but are not limited to:
   1. Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for Data Integrity Specialist Jobs at Nesher Pharmaceuticals (USA) LLC