QS Specialist Job in Lakewood 08701, New Jersey Us
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review batch and process related information as well as environmental trending in support of Annual Product Review (APRs).
- Generates APR for products distributed in the US and Europe and maintains the schedule for existing and new products.
- Responsible for the day to day administration of the failure investigation system (TrackWise)
- Generates and supports investigations, define investigational strategy and perform root cause analysis in support of troubleshooting and investigations.
- Review of process, product and / or environmental related data in support of APR generation and failure investigation
- Performs trending of data in support of process or product attribute trending.
- Performs gap analysis of key quality indicators to ensure continuous quality improvement.
- Interfaces with internal and external customers in problem resolution, and continual improvement.
- Notifies management of quality/compliance trends and service failures.
- Facilitates changes to SOPs, policies, training materials, and other documents for a technical discipline.
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.
EXPERIENCE
Experience: A minimum of three (3) years experience in the Pharmaceutical, diagnostic, or Biotech industry. Direct experience with TrackWise system. Direct experience generating or supporting Annual Product Reviews (APR). Experience performing investigations.
LANGUAGE SKILLS
Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints.
MATHEMATICAL SKILLS
Ability to apply advanced mathematical concepts and perform basic statistical computations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
REASONING ABILITY
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
None.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee 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 employee is regularly required to talk or hear; stand; walk; and sit. The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; and climb or balance.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing 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 employee must occasionally observe production, packaging or testing activities in the field. The noise level in the work environment is moderate.
SUPPLEMENTARY INFORMATION
This description is based in management's assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for the management and employees, but it does not purport to be an exhaustive list of all the elements of the job. Management reserves the right to modify the description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet production, scheduling or staffing needs.
The job descriptions reflect the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.
Click Here To Apply
http://dptlabs.hua.mytalentlink.hrdpt.com/pm_module/cgi-bin/click.cgi?job_id=92site_id=35