Quality Reviewer I
Location: West Point
Posted on: October 1, 2024
|
|
Job Description:
Prominent global pharmaceutical company is seeking a Quality
Reviewer I to work in West Point, PA
This is a twelve (12) month contract position.
Must be able to work either or both of the following shifts:
1st shift, Tuesday - Saturday
2nd shift, Sun - Thursday
Maximum pay is $34.75/hour.
Summary:
The Contractor Quality Specialist (CQS) provides direct Quality
support to a production area as part of a Quality IPT (Integrated
Production Team) operating model. The CQS, with guidance from the
IPT Quality Leadership team, ensures product / process quality and
performs activities to facilitate the release of product to the
marketplace. The CQS performs 100% process document / log book
audits for accuracy and completeness and works closely with the
assigned End to End (E2E) in a team environment to ensure timely
review and documentation is done right first time. The Contractor
Quality Specialist will become knowledgeable in Federal and other
regulatory agency requirements and cGMPs to assure that all areas
in compliance, and will train on and gain competency in activities
to facilitate release of product for assigned End to End (E2E).
KEY TASKS & RESPONSIBILITIES:
Performs 100% audit of process documents / log books to ensure
completeness and accuracy for assigned End to End (E2E).
Maintains any tracking databases and logs associated with this
review.
Coordinates with Production to discuss, resolve, and eliminate
documentation observations.
Actively participates in the Tier process and uses this forum to
escalate concerns and best practices.
Collaborates with IPT members in the identification and
implementation of continuous improvement initiatives and action
plans.
Prioritizes review of process documents / log books in order to
maximize cycle-time efficiency.
Performs SAP transactions required to document Batch Record
review.
Requirements:
At least one year of relevant post-degree work experience in a
laboratory, manufacturing, or quality position.
Evidence of good oral and written communication skills, i.e.
effective presentation of concepts and ideas, as well as
interpersonal and conflict resolution skills.
Attention to detail, flexibility and an awareness of production and
attendant quality control problems.
Basic understanding of GMPs and of regulatory requirements as they
apply to the pharmaceutical field or a related area.
Familiarity with vaccine and/or pharmaceutical processing.
Familiarity with manufacturing batch records is a key skill
necessary for success in this position; prior batch record
experience is a strong plus.
Experience in quality assurance audits or inspection of vaccine or
pharmaceutical manufacturing areas is beneficial.
Bachelor's degree. Technical emphasis in an appropriate scientific
or engineering field preferred; candidates with majors in other
fields will be considered if accompanied by significant relevant
experience.
Note: Titers may be required
We are an equal employment opportunity employer and will consider
all qualified candidates without regard to disability or protected
veteran status.
Keywords: , Philadelphia , Quality Reviewer I, Executive , West Point, Pennsylvania
Click
here to apply!
|