Sr. Quality Specialist (GxP Deviations and CAPAs) - Purdue Pharma : Job Details

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led bya 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: Integrity and Courage, underpinned by Innovation, and always in Collaboration with 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! Job Summary The Sr. Quality Specialist is a first shift position that reports to the Associate Director, Quality and is primarily responsible for authoring GxP deviations and Corrective and Preventative Actions (CAPAs). The role also provides support for change control activities and back up for certain MQA activities. Primary Responsibilities

• Utilize root cause analysis tools to drive to root cause of GxP deviations. Complete impact analysis and identify appropriate corrective actions to prevent recurrence.
• Collaborate with SMEs from other departments while hosting SME team meetings to ensure a cross functional evaluation is completed.
• Oversee the administration of the prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
• Perform activities for MQA (i.e. Packaging line clearances, manufacturing room clearances, inspection of third-party contractor lots. Maintains documentation in accordance with internal procedures and regulatory requirements (i.e. GMP, SOPs, etc.)
• Work closely with Logistics / Supply Management on scheduling/distribution needs to appropriately manage workload.
• Prepare Investigation and Change Control elements for Annual Product Review Reports (APRs).
• Collaborate with other facility colleagues to assure alignment of cGMP documentation practices where appropriate.
• Support and maintain an environment that fosters communication and teamwork within QA and related departments.
• Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
• Perform other related assignments and duties as required and assigned. Education and Experience Requires a Bachelor's degree, preferably in a scientific discipline, with a minimum of 6 years of experience in a pharmaceutical or related industry or graduate degree (MS preferred) with two years of experience in a pharmaceutical or related industry . Demonstrated sound understanding, well developed working knowledge and ability in primary discipline. Necessary Knowledge, Skills, and Abilities Investigation into any unexplained discrepancies must be evaluated in terms of cGMPs, FDA requirements, NDA commitments and impact on product quality, safety and efficacy. Incumbent must be able to drive deviations to determine true root cause and identify appropriate CAPAs to prevent recurrence.
  • Assist Quality team to meet day-to-day assignments.
  • Demonstrate excellent understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing processes.
  • Identify and resolve in-depth issues through collaboration with others.
  • Partner with colleagues in identifying and resolving potential compliance concerns.
  • Interface with appropriate Warehousing, Planning, Pharmacy, Operations and Quality management to implement the procedural requirements as outlined and within internal operating procedures.
  • Identify and propose opportunities for continuous improvement to quality systems.
  • Effectively perform root cause analyses and determines corresponding corrective measures.
  • Working knowledge of TrackWise is a plus. 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 following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
    • Ability to work a 10 hour per day/4-day work week; 40 hours per week. Additional Information cGMPs, FDA requirements and regulatory commitments govern the QA function of the Sr. Quality Specialist, in addition to the foregoing, the incumbent must demonstrate:
      • The ability with using appropriate and effective, written and verbal communication skills.
      • Strong capabilities in project management.
      • The ability to oversee the corrective action process, including identification of the root cause and implementing and monitoring corrective measures.
      • The ability to foster teamwork through the use of interpersonal skills. Minimum required education, experience, knowledge, skills and abilities are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities. 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. The position is an Onsite role, and the candidate must reside in NC. Relocation is not offered for this position. Purdue Pharma does not sponsor or facilitate any U.S. work/intern or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma. 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:
        • Equal Employment Opportunity is the Law (EEO)
        • EEO is the Law Poster Supplement
        • 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 or hiring process, please email the Talent Acquisition team at [email protected]. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance. The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee. Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received. Beware of scams involving fraudulent job postings misrepresenting the Company. Recruitment fraud is a scam offering fictitious job opportunities. This type of fraud is normally perpetrated through fake websites, or through unsolicited e-mails claiming to be from the Company. These emails request that recipients provide personal information, and sometimes payments. To help protect yourself from fraudulent recruitment scams, we encourage you to consider the following:
          • The Company never requests money or fees for any purpose during or after the hiring process.
          • The hiring process involves at least one interview (phone, virtual or in-person). The Talent Acquisition team corresponds from email addresses with the domain @pharma.com .
          • The Talent Acquisition team does not request or require personal documents like bank account details, or credit card information as part of the recruitment process. If you are in doubt or unsure about the source of job posting or job offer, please visit the Career section on the Company website to verify the job or contact the Company directly at [email protected].