Quality Specialist III, GxP Training (Onsite)
Company: Purdue Pharma
Location: Wilson
Posted on: March 16, 2023
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Job Description:
Quality Specialist III, GxP Training (Onsite)
4701 International Blvd, Wilson, NC 27893, USA
Req #171
Monday, November 21, 2022
Purdue Pharma L.P. and its subsidiaries develop, manufacture and
market medications and consumer health products to meet the
evolving needs of healthcare professionals, patients, and
caregivers. We were founded by physicians, and we are currently led
by a physician. Beyond our efforts to provide quality medications,
Purdue is committed to supporting national, regional and local
collaborations to drive innovations in patient care. Privately
held, Purdue is pursuing a pipeline of new medications through
internal research & development and strategic industry
partnerships.
For close to two decades Purdue has engaged in many initiatives to
stem prescription opioid abuse. We are committed to bringing
lifesaving relief to communities and individuals suffering from
substance use disorder and overdose.We are currently developing or
supporting the development of two essential life-saving opioid
overdose reversal medications and have the capability to
manufacture others for medication assisted treatment. Providing
these medicines has the potential to improve and save countless
lives.
We are driven by our purpose:Compassion for patients and excellence
for science inspire our pursuit of new medicines.
We are building an exciting path forward, and we are committed to
recruiting a dedicated team of professionals who advance our
expertise through a commitment to Purdue's Values:
IntegrityandCourage, underpinned byInnovation, and always
inCollaborationwith each other.
At Purdue Pharma and our subsidiaries, you have a unique career
opportunity to work differently, uncover and seize new
opportunities, and take a hands-on, ownership approach to your
work.We go beyond traditional roles and find creative ways to
extend our skills and interests, challenging ourselves to
contribute in different, meaningful ways. We strive to create an
environment where you can bring your best to work each day.We
welcome the opportunity to have you on our team!
We respect diversity and accordingly are an equal opportunity and
an affirmative action employer. Qualified applicants will receive
consideration without regard to: actual or perceived race, sex or
gender (including pregnancy, childbirth, lactation and related
medical conditions), national origin, ancestry, citizenship status,
religion, color, age, creed, sexual orientation, marital status,
gender identity or gender expression (including transgender
status), protected medical condition as defined by applicable state
or local law, genetic information, physical or mental disability,
veteran status and military service, or any other characteristic
protected by local, state, or federal laws and ordinance.
For more information about your rights under Equal Employment
Opportunity, visit:
USERRA Rights
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
E-Verify (English and Spanish)
Right to Work (English and Spanish)
Pay Transparency Nondiscrimination Provision (English)
Pay Transparency Nondiscrimination Provision (Spanish)
We strive to make our Career opportunities website accessible to
all users. If you need an accommodation to participate in the
application process, please email: careers@pharma.com. This email
is not for general employment inquiries or vendors; rather it is
strictly for applicants who require assistance accessing our
careers website.
Job Summary
The Quality Specialist III, GXP Training is required to support and
enhance the quality training programs related to applicable
regulatory requirements, as well as local and global processes.
Primary duties include business administration of the Cornerstone
on Demand (CSOD) Learning Management System, including but not
limited to, review and assessment of quarterly release revisions,
curricula maintenance, data entry and reporting. In addition, the
position evaluates existing manufacturing training programs and
data trends to identify training needs and develop new training.
This evaluation assesses the adequacy of training materials and
programs in a GxP environment. Position will work closely with IT,
manufacturing business units and site management to
streamline/progress training needs.
Primary responsibilities:
Provide business administration support for the CSOD system for the
Wilson site, including assessment of quarterly system releases vs.
business needs.
Support validation testing of system changes, upgrades from an SME
perspective.
Meet with business functions routinely to identify, recommend, and
implement improvements to the training function to make it more
effective and efficient in supporting business objectives and
compliance requirements. This should reflect industry best
practices.
Facilitate the development/maintenance of training curricula for
the RTP and Wilson sites.
Perform training needs analysis and effectiveness assessments as
deemed appropriate. Coordinates/delivers other regulatory training
as required.
Ensure training documentation is accurate and compliant with Good
Documentation Practices
Coordinate with Training colleagues at the Stamford site to develop
and implement training programs to improve training effectiveness,
standardize practices and optimize operations.
Establish and maintain industry contacts on current compliance and
training issues by participation in external Training industry
groups.
Proactively support company priority initiatives with activities
that are outside planned responsibilities and objectives.
Maintain electronic and paper GXP training files, ensures files are
current and in compliance with regulations and internal
procedures.
Coordinate with LMS owner to provide training records as requested
in support of external and internal audits.
Provide SME input on deviations, Laboratory Investigations, Planned
Deviations, Change Controls and CAPA.
Provide training direction, analysis, and guidance regarding
quality related compliance.
Perform other related assignments and duties as required and
assigned.
Education and Experience
BS required and 4 years minimum relevant experience, or equivalent
level of experience in pharmaceutical or related industries; or
graduate degree (MS preferred) with 2 years minimum relevant
experience
Necessary Knowledge, Skills, and Abilities
A thorough understanding of cGMP and excellent working knowledge of
FDA regulations
Experience in managing curricula in Cornerstone on Demand or
similar LMS
Preferred experience in the creation of Manufacturing/Laboratory
On-boarding programs
Experience in establishing training effectiveness programs
A strong ability to resolve and communicate technical issues, and
perform root cause analysis
Demonstrated ability to act as a functional expert and provide
input as such
Ability to negotiate needed actions and manage difficult
interactions effectively.
Knowledge of computerized support tools and training software
Supervisory Responsibilities (if Applicable)
This position has no direct reports.
Physical and Environmental Requirements
Perform job functions in various positions that may require
sitting, stooping, balancing, kneeling, crouching, twisting, and/or
reaching. While sitting for an extended period of time on a routine
basis, incumbent may use the followingequipment: Personal computer,
telephone/ other voice communication devices, copier, fax,
scanners, or other specialized equipment used in an office
setting.
Additional Information
The job description is not an exhaustive list of all functions that
the employee may be required to perform, and the employee may be
required to perform additional functions. Additionally, the company
may revise the job description at any time.
Other details
Job Family
Quality
Pay Type
Salary
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