Quality Assurance Specialist

Summary

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

Essential Duties and Responsibilities

• Conducts activities associated with the investigations process 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.
• Determines, through collaboration with peers and superiors, appropriate corrective actions to resolve deficiencies identified during investigations through the CAPA process.
• Manages change controls through the review/approval process, assessing the changes to ensure all procedural requirements have been met.
• Develops trending & metrics reporting for Quality Systems to assure compliance, escalate past due items, provide visibility of problem areas, and assists in streamlining workflow processes.
• Involved in writing, reviewing and revising SOPs to reflect current processes.
• Participates in FDA audits and other regulatory inspections.
• Assembles and evaluates data for Annual Product Reviews.
• Performs QA review of laboratory data, SOPs, Protocols, Methods, and Specifications.
• Maintains database for Certificates of Analysis and Cleaning Validation Data.
• Maintains database and hard copy file of Development Methods, Specifications, and Protocols and Reports.
• Performs periodic walk-through audits of the laboratory.
• Performs QA review of Utility and Facility Activities. 
• Reviews Master Batch Records and Master Packaging Records for completeness and for inclusion of all QA tasks and requirements.  Such records may be associated with product development or commercial production. 
• Provides team leadership, as required, as well as team member support.
• Serves as a member of internal audit teams and prepares written reports, as directed by internal auditor.
• Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.
• Performs 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.
• Five years' experience in Quality Assurance role that involves conducting investigations and follow-up with CAPA processes, performing data reviews, 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.

1. 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.

Current Openings for Quality Assurance Specialist Jobs at Nesher Pharmaceuticals (USA) LLC