Quality Specialist II, QA Production Support (Onsite Role: 8p-6:30a)
Company: Purdue Pharma
Location: Wilson
Posted on: January 20, 2023
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Job Description:
Quality Specialist II, QA Production Support (Onsite Role:
8p-6:30a)
4701 International Blvd, Wilson, NC 27893, USA
Req #170
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 Assurance (QA) Specialist II, QA Production Support is
a position on the Hybrid Shift.The candidate must demonstrate
thorough understanding, knowledge, and ability in primary
discipline.The QA Specialist II, QA Production Support is
responsible for performing incoming sampling of materials, support
room /line clearances and provide QA input into production event
resolution to assure that quality operations are in conformance to
GMP requirements. Also responsible for identifying compliance
deficiencies, providing QA SME input into investigations as
required and assisting with the resolution plan.
Primary Responsibilities
Perform sampling, and inspection on incoming commercial and
experimental/clinical raw materials, components, and
intermediates.
Perform raw material component review to ensure correct quantities,
labeling and visual appearance.
Oversee the administration of prompt event evaluation,
investigation, closure and follow-up of process/equipment
discrepancies and related areas as well as identify opportunities
for continuous process improvements.
Comprehend and adhere to all related SOPs, company policies, cGxPs,
and regulatory requirements.
Comprehend and adhere to all pertinent Health and Safety
regulations, policies and procedures and the required use of all
approved and issued Personal Protective Equipment.
Execute activities/tasks (i.e., sampling, cleaning, packaging
component testing.) in accordance with approved SOPs, schedules and
communicates expected processing times for incoming raw materials,
components, and intermediates to appropriate Warehousing, Planning,
Operations, Pharm Tech, and Quality management.Efficient and
proactive in executing assigned activities.
Maintain current training status and close all training gaps in a
timely fashion.
Prepare and maintain tracking/testing systems, (i.e., LIMS, SAP,
Logbooks, OCR, etc.) which are used for testing and to reflect
status of samples.Reports status to appropriate laboratory,
manufacturing and planning groups at pre-determined intervals.
Provide timely day-to-day decisions on compliance related issues in
Production, Warehouse/Distribution, Facilities, Incoming QA,
Quality Control and Stability areas based on expertise and
collection of independently gathered information.
Assess accuracy and compliance of plant SOP's as a SOP reviewer and
approver and works with SOP author for timely approvals.
Communicate daily with supervision and others within work group as
related to specific job function and demonstrate the ability to
communicate with others outside of work group.
Demonstrate a level of consciousness to safety and health related
activities as evident by the daily application of requirements
specific to job function; Recognize safety and health related
issues and report to supervision.
Support and maintain an environment that fosters communication and
teamwork within Quality Assurance and related departments.
Perform other related assignments and duties as required and
assigned.
Education and Experience
BS required with 2 years minimum relevant experience, or equivalent
level of experience in pharmaceutical or related industries; or
graduate degree (MS Preferred) with one-year minimum
experience.Internal candidates require minimum 5 years
pharmaceutical experience.
Necessary Knowledge, Skills, and Abilities
Basic understanding of applicable regulatory requirements as it
relates to job function demonstrated by adherence to policies and
procedures;
Basic ability to perform computer transactions related to job
functions demonstrated by right first-time measures;
Ability to perform job function using appropriate instrumentation
and applicable techniques demonstrated by efficient and accurate
completion of work;
Ability to apply technical knowledge and experience in performing
job functions as is displayed through independence in daily
performance of work;
Ability to apply and evaluate systems and procedures for
improvement opportunities demonstrated through discussion of
recommendations with supervision;
Ability to overcomes obstacles to achieve results as indicated by
ability to resolve issues and meet timelines;
Demonstrate application of industry best practices and specific
regulatory requirements for evaluation of systems and procedures
for improvement opportunities and communicates results and ideas to
supervision on a regular basis;
Ability to troubleshoots and recommend improved methods or
techniques of performing job function or utilizing instrumentation
demonstrated by ability to achieve results, gain right first-time
output, and improve efficiency;
Ability to utilize multiple IT systems required for job performance
and utilize reports for analysis demonstrated by consistent right
first time results and independent resolution of issues.
Documentation Competencies
Complete required documentation accurately according to
procedure;
Identify potential concerns in data that is reported and
communicates concerns to supervision;
Perform peer review of data with consistency and accuracy, and
assists in resolution of documentation errors;
Identify unusual occurrences or data that is aberrant as compared
to acceptance criteria or routine analysisand communicates results
to supervision;
Document and evaluate technical data for indications of negative
trends and reports trends to management;
Summarize and evaluate data for reporting and analysis and reports
results to management;
Independently resolve documentation errors with other appropriate
departments achieving acceptable corrective action;
Act as reviewer of data generated in work group with consistency
and accuracy, and assists in resolution of documentation
errors.
Problem Solving Competencies
Recommend solutions to issues related to the job function in a
timely manner;
Troubleshoot and provide immediate solutions for issues related to
job function;
Execute corrective actions to prevent reoccurring problems.
Communication/Team Competencies
Demonstrate ability to communicate with others outside of work
group as related to the specific job function;
Contribute to functional areasoutside of work group contributing
expertise as related to the specific job function;
Safety Awareness
Evaluate work related activities to eliminate potential safety or
health related issues and implements corrective action.
Supervisory Responsibilities (if Applicable)
There are no direct reports for this role.
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 following
equipment:Personalcomputer,telephone/othervoicecommunicationdevices,
copier, fax or other specialized equipment used in an office
setting;
Walk,climbandworkonstepladders,stairs,and/orplatforms
whileperforming line/room clearances and defect
resolution/investigations;
Takesampleswhichmayrequirestretching,bending,ortwistingtoremoveproduct
from the equipment/containers (i.e. IQA raw material sampling and
label/ outsert/ bottle/closure sampling/testing). Moving drums/bags
of raw materials and label rolls/boxes which range in weight from
10-50 lbs;
Performinspectionsoncleanedanddisassembleproductionequipmentwhichmay
require pulling, pushing, twisting, and crawling/crouching to
remove equipment shields and panels and ensure equipment is clear
of foreign product;
Whennecessary,wearappropriatePersonalProtectiveEquipmentincludingPAPR
(Powered Air Purifying Respirator), safety glasses, protective
gloves, and safetyshoes;
Ability to work a 10 hour per day/4-day work week; 40 hours per
week with overtime as required.
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
Apply Now
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