Nesher Pharmaceuticals (USA) LLC

Quality Systems Specialist Jobs at Nesher Pharmaceuticals (USA) LLC

Quality Systems Specialist Jobs at Nesher Pharmaceuticals (USA) LLC

Sample Quality Systems Specialist Job Description

Quality Systems Specialist

SUMMARY
Perform investigations, assessments, audits, and other related tasks that fall under the broad category of Quality Systems functions. Such tasks will include conducting investigations associated with deviations, events and complaints; providing general Quality Assurance assessment of investigations; determining and/or completing corrective and preventive actions (CAPAs) associated with investigations; reviewing data as needed to support investigations such as laboratory data, Master Batch Records and Master Packaging Records, and Validation Protocols and Qualifications; participating as a member of internal audit teams, conducting Vendor Oversight, participating in APRs, and evaluating change controls for impact on other cGMP systems.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Conduct activities associated with the investigation process (deviations, events and complaints) to meet needs of company and to comply with all necessary regulations. Such activities may include conducting investigations or evaluating investigations conducted by other departments or other Quality functions.
Determine, through collaboration with peers and superiors, appropriate corrective actions to resolve deficiencies identified during investigations through the CAPA process.
Manage change controls through the review/approval process, assessing the changes to ensure all procedural requirements have been met.
Develop trending and metrics reporting for Quality Systems to assure compliance, escalate past due items, provide visibility of problem areas, and assist in streamlining workflow processes.
Conduct Vendor Audits and write associated audit reports, as assigned.
Involved in writing, reviewing and revising SOPs to reflect current processes.
Support FDA audits and other regulatory inspections.
Assemble and evaluate data for Annual Product Reviews.
Provide team member support.
Serve as a member of internal audit teams and prepare written reports, as assigned.
Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES
Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices, FDA, DEA and other legislation regulating the production operation.
PC proficiency using Microsoft Office required; Trackwise a plus.
Outstanding oral communication and conflict resolution skills with all levels of the organization.
Ability to think critically and apply critical thinking processes to investigations, CAPAs, auditing, and data reviews.
Highly organized and able to work comfortably with accelerated work pace.

EDUCATION/EXPERIENCE

Bachelor's degree in the sciences or related technical field.
Three years' experience in a Quality role that involves conducting investigations, CAPA processes, managing Change Control programs, writing Annual Product Reviews, and/or other QA-related functions, 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:
1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
2. 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.
3. 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: 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.

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