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Quality Specialist II, QA Production Support (Onsite Role: 8p-6:30a)

Company: Purdue Pharma
Location: Wilson
Posted on: November 25, 2022

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:











  • EEOCKnow Your Rights
  • EEOC Know Your Rights (Spanish)



  • 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



































                  • 4701 International Blvd, Wilson, NC 27893, USA

















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Keywords: Purdue Pharma, Wilson , Quality Specialist II, QA Production Support (Onsite Role: 8p-6:30a), Other , Wilson, North Carolina

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