Quality Specialist
Company: Planet Pharma
Location: Lansdale
Posted on: February 25, 2021
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Job Description:
Please Note:* 1 year contract* Reference Number: 322843*
Experience with batch records* We are unable to sponsor at this
timeSummary:* The Quality Specialist provides direct Quality
support to a production area as part of a Quality 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).
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.Qualifications:Education: * 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
experienceRequired Experience and Skills: * 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.Preferred
Experience and Skills: * 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. * Familiarity with computer
systems (SAP, LIMS, electronic batch records) is a plus
Keywords: Planet Pharma, Philadelphia , Quality Specialist, Other , Lansdale, Pennsylvania
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