Sr. Quality Specialist I, Quality Systems (On-site)

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 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: 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 I is primarily responsible for authoring GxP deviations and CAPAs. The role also provides support for Development Projects and certain Manufacturing Quality Assurance (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 elements for Annual Product Review Reports (APRs).
• Collaborate with other facility colleagues to ensure alignment of cGMP documentation practices where appropriate.
• Support and maintain an environment that fosters communication and teamwork within QA and related departments.
• Ensure compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
• Provide QA support for Development projects at the Wilson facility including registration, validation and clinical activities.
• 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 4-7 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

• Evaluate and investigate unexplained discrepancies in alignment with cGMPs, FDA requirements and commitments, and overall impact on product quality, safety, and efficacy.
• Drive deviation investigations to accurately determine true root cause and define effective corrective and preventive actions (CAPAs) to avoid recurrence.
• Support the Quality team with daily operational assignments and priorities.
• Demonstrate strong knowledge of cGMPs, FDA regulations, and pharmaceutical manufacturing processes.
• Identify and resolve complex issues through collaboration with crossfunctional partners.
• Collaborate closely with colleagues to recognize and address potential compliance concerns.
• Interface with Warehousing, Planning, Pharmacy, Operations, and Quality Management to ensure adherence to procedural and internal operating requirements.
• Recommend and contribute to continuous improvement initiatives within quality systems.
• Perform thorough rootcause analyses and determine appropriate corrective measures.
• Utilize Veeva or similar quality management systems (working knowledge is a plus).
• Ensure all Quality Assurance activities comply with cGMPs, FDA requirements, and applicable regulatory commitments.
• Demonstrate strong written and verbal communication skills to convey complex quality and compliance information effectively.
• Utilize effective communication techniques to influence, collaborate, and support crossfunctional partners.
• Apply projectmanagement capabilities to plan, execute, and monitor QA initiatives and deliverables.
• Oversee the corrective action process, including conducting thorough rootcause analyses, implementing, and tracking corrective and preventive measures.
• Foster a collaborative and productive team environment through strong interpersonal and relationshipbuilding skills.

Supervisory Responsibilities (if Applicable)

The position has no direct reports.

Physical and Environmental

• Ability to perform job duties in a variety of physical positions, which may include sitting, stooping, balancing, kneeling, crouching, twisting, and reaching, as required by daily tasks.
• Ability to sit for extended periods while routinely using standard office equipment such as a personal computer, telephone or other communication devices, copier, fax machine, scanner, and other officebased tools.
• Ability to work a 10hour per day, 4day workweek (40 hours per week), with overtime as business needs require.

Additional Information
Relocation is not offered for this position.

Purdue Pharma does not sponsor or facilitate any U.S. work 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.

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.

We are an Equal Opportunity 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:

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)

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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.