The Investigator is responsible to lead, conduct and document investigations relating to non-conformances and/or complaints within a GMP Pharmaceutical packaging organization. The Investigator will utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of non-conformances/complaints. The Investigator will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation. The Investigator will lead, as necessary, the implementation of associated corrective and preventative actions through collaboration, teamwork, and influence. The position will work closely and in collaboration with internal and occasionally external stakeholders. The Investigator also has responsibilities for data generation, process evaluation and performance metrics for the purposes of customer communication and driving continuous improvement.
Must possess a working knowledge of FDA regulations pertaining to Pharmaceutical/Pharmaceutical Packaging Operations and a high level for detail and accuracy. Scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, investigation conclusions, and documentation supporting recommendations for product impact assessments could expose the company to significant risk or economic loss.
Essential Duties and Responsibilities:
Supervisory Responsibilities:
None
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements:
Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.
Education and/or Experience:
Bachelor's degree is preferred with one to three years related experience or Associate's Degree with three to five years of related experience. Experience in the packaging or inspection of pharmaceutical products or related industry is required. Experience in the design, documentation, operation, maintenance, and/or improvement of biopharma facilities is preferred. Outside certification of quality skills and practices (i.e., ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired.
Mathematical Skills:
Ability to apply moderately complex mathematical operations including an understanding of statistical skills.
Language Skills:
Ability to effectively communicate (written and verbally) with the following groups:
Internal Communication: Quality, Operations, Sales, Customer Service, Project Management, Validation, and Engineering teams.
External Communication: Represents Quality as the subject matter expert (SME) for customers and regulatory agencies on Investigations related non-conforming events.
Written Skills:
High level of writing and verbal skills, ability to provide clear, concise, and legible communication within investigation reports, internal and external correspondence, such as memos to file, electronic mail and investigation reports and procedure writing.
Reasoning Ability:
Ability to independently make rational decisions pertaining to objective root cause and CAPA is required. Ability to trouble shoot and resolve problems effectively and efficiently. Ability to think critically about an issue and ask pertinent questions.
Computer Skills:
Intermediate Windows applications including the Microsoft Office Suite and electronic QMS.
Physical Demands:
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
Work Environment:
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.
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