Position: Quality - Specialist, QA Engineering 59748-1
Location: Warren NJ 07059
Duration: 12+ months (possibility of extension for the right candidate depending on performance)
Pay rate: $62/ hour on W2
100 % Onsite role, Warren NJ
Work Schedule: Monday - Friday, normal business Hours
Position Summa
ryThe Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with the client's policies, standards, procedures, and Global cGMP. Functional responsibilities for the incumbent include facilitating Change Control Review Board (CCRB) and record tracking meetings (e.g. Change Actions weekly) as applicable, driving proactive and corrective improvements within Operations, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on-time closure, evaluation of new requirements and emerging regulations, providing user support for the different Quality Systems as a site lead which includes integration activities and generation and review of Site Quality Metric
s.
Duties/Responsibilitie
s :
Ensure control of systems, processes, and products through the facilitation of C
CRB.
Represent site and provide impact assessment for global changes at Global
CCRB
Monitor and track external audit/inspection commitments to ensure timely cl
osure.
Track site change controls and ensure appropriate requirements are identified and completed for implemen
tation.
Provide weekly change control due date updates to the Tier board
metrics.
Must be skilled in planning and organizing, decision-making, and building relat
ionships.
Familiar with the Veeva Vault Q
MS system.
Able to effectively
multi-task.
Reporting
Relationship
Reports to Senior Manager, Q
A Engineering
QualificationsEDUCATION
AND EXPERIENCE
A B.S. degree is required, as well as a minimum of five years of experience in the pharmaceutical or re
lated industry.
Experience with cGMP manufacturing, Quality,
and compliance.
Excellent verbal and written comm
unication skills.
Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, an
d CAPA management.
RE
QUIRED COMPETENCIESMust have advanced knowledge and experience with cGMP manufacturing, Quali
ty, and compliance.
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe an
d compliant process.
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a hi
gh level of accuracy.
Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majorit
y of the job function.
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage the development of technical or scientific initiatives and activities by i
nterdisciplinary teams.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem-solving, conflict management, planning and organizing, resource allocation, coaching others,
and analytical thinking.
Must possess an independ
ent mindset and tenacity.
Requires moderate direction to complete more complex tasks; completes routine tasks with
little or no supervis
ion.
Work is self-directed.
Confident in making
decisions for minor issues.
Routinely recognizes Qualit
y issues and solves problems.
Proposes solutions for complex issues and works with management to resolve them. Follows established procedures
and performs work as assigned.
Intermediate to advanced ability to interpret results and situations and articulate
recommendations for resolution.
Is recognized Subject
Matter Expert within the group.
Provides guidance to other employees in th
e interpretation of complex data.
Capable of providing input within the department
and cross-functional teams. Build
relationships internally with
in and with cross-functional teams.
Contri
butes to goals within the workgroup.
Able to recognize conflict and notify management with pro
posed recommendations for resolution.
Able to prepare written communications and communicate problems to
management with clarity and accuracy.
Able to write and r
eview reports with clarity and brevity.
Able to effectively multi-tas
k and execute project management skills.
Know
ledge of US and global cGMP requirements.
Underst
anding of aseptic manufacturing processes.
Teamwork and ability to work effectively across functional group
s and teams to ensure requirements are met.
Ability to make independent and objective dec
isions and to work with minim
al supervision.
WORKING CONDITIONS: (US Only)Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no ab
normal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that
are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other
job-related duties as requested by management.