Sr. Quality Specialist I, Documentation Systems

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 Quality Assurance (QA) Sr. Quality Specialist, Documentation Systems is a position that encompasses several Quality Systems. The position conducts technical quality compliance related activities in accordance with GxP regulations and internal Standard Operating Procedures. Primary responsibilities include conducting product complaint investigations, administration of site change control program, compiling of annual product reviews, coordinating documentation in support of global submissions, routine document revisions, document issuance, and documentation archives.

Primary Responsibilities:

• Perform complaint investigations for Purdue manufactured products and work closely with Supplier Quality Assurance to obtain required 3rd party investigative details, as required.
• Escalate product complaints as deemed necessary for field action and prepare field alerts as applicable.
• Author and/or review and implement SOPs to ensure compliance with current Purdue standards and cGMP as related to areas of responsibility.
• Compile, review, and facilitate approval of Annual Reports and Annual Product Reviews.
• Assist with administration of site Change Control Program.
• Assist with the generation of monthly and quarterly metrics as required by SOPs and review metric reports to ensure the appropriate metrics are being captured.
• Assist with administration of the electronic documentation management system.
• Ensure that documentation is maintained/archived in accordance with internal procedures and regulatory requirements (i.e., GxP, etc.).
• Compile global regulatory submission certifications and documentation as required by business partners for ex-US submissions.
• Provide support with product and process investigations and data analysis, as requested by Quality management.
• Utilize knowledge of regulatory requirements to identify, describe, and communicate issues and participate in problem resolution and corrections.
• Issue of documents, including but not limited to Master Batch Records, Write-up Pages, Logbooks and Lab Notebooks.
• Participate in resolving deviations associated with the Documentation Systems group.
• Participate in the management of the document periodic review process.
• Support and maintain an environment that fosters communication and teamwork within Quality Assurance and related departments.
• Process documents and requests using applicable quality systems.
• Maintain current knowledge base within relevant technical disciplines of FDA regulations and awareness of the necessity and impact of compliance of the business.
• Communicate and participate in identified improvements as well as mitigation of potential gaps.
• Support regulatory inspections, as necessary.
• Perform other related assignments and duties as required and assigned.

Education and Experience:

Bachelor's degree required and 6 years minimum relevant experience in supporting and maintaining quality systems, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 4 years minimum relevant experience.

Necessary Knowledge, Skills and Abilities:

• Demonstrated sound understanding well developed working knowledge and ability in primary discipline.
• A thorough understanding and working knowledge of Quality Systems and tools.
• Knowledge of GxP regulations in other disciplines and awareness of impact on cross functional areas.
• The ability to recognize changes in priorities and plan as needed; to look for opportunities arising out of changing parameters.
• The ability to effectively identify and communicate challenges and their impact in a timely manner and participate in problem resolution.
• The ability to provide guidance to personnel from a wide range of departments related to complaint investigations, change controls, annual product reviews, documentation issuance, handling and archival, and Veeva QMS and DMS.

Supervisory Responsibilities (if applicable):

The incumbent reports to the Associate Director, Quality. The position has no direct supervisory responsibility, however, the incumbent must:

• Possess the ability to independently prioritize workload.
• With minimal guidance and supervision, conducts routine and non-routine activities in the primary discipline with minimal guidance and supervision.
• With minimal guidance and supervision, plans, performs, and reports to management regarding QA and compliance activities.
• May interact with other departments/teams within the Company and with external regulatory agencies and business partners.

Physical/Environmental

• 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, or other specialized equipment used in an office setting.
• Individual may move various items (i.e., boxes, carts, files, etc.) by hand or manual hand carts.
• Must be able to work a 10.5 hour per day/4-day work week; 40 hours per week.

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.