Sr. Quality Specialist I, Method Development

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! EMPLOYER: Purdue Pharmaceuticals L.
P.
TITLE: Senior Quality Specialist I, Method Development Chemist LOCATION: 4701 International Blvd.
, Wilson, NC 27893 DUTIES: Perform a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product samples, and stability samples in accordance with cGMP, GLP, DEA, and company policies and procedures.
Author and review protocols for method development, method validation, method transfer, and/or process validation.
Execute protocol testing, data review, report writing, and report reviewing.
Conduct equipment validations IQs, OQs, PQs, and MQs, if necessary.
Provide assistance and technical support to other groups with chemical testing needs and perform troubleshooting of analytical methods and instrumentation.
Serve as an analytical project lead for all assigned projects.
Actively participate in method development, validation, verification, and transfer activities with no direct supervision.
Perform analytical testing in a timely and organized manner following cGMP, GLP, DEA, and company policies and procedures without direct supervision.
Accurately document all analytical activities and report all generated data.
Operate and maintain analytical instrumentation following site procedures.
Write, revise, develop, and evaluate protocols, reports, and analytical test procedure.
Provide training and assistance to less senior analysts.
Assist with analytical investigations and troubleshooting.
REQUIREMENTS: Master’s degree in Chemistry or a closely related scientific field and 4 years of experience in the job offered or a related pharmaceutical industry laboratory occupation.
Alternatively, employer will accept a bachelor’s degree in Chemistry or a closely related scientific field and 6 years of experience in the job offered or a related pharmaceutical industry laboratory occupation.
Al applicants must have 3 years of experience with all of the following: testing small molecule oral solid dose pharmaceutical products utilizing USP and EP monographs with applicable general notices; documenting laboratory work following cGMPs and FDA requirements; developing and validating analytical test methods following FDA and ICH requirements; authoring and reviewing validation protocols, validation reports, and analytical test methods; and at least two (2) of the following analytical technologies: HPLC, GC, Dissolution, Automation (TPW3, MultiDose), or Spectroscopy (FTIR, Raman).
TO APPLY: Send resume to careers@pharma.
com and reference code 18595.
00076.
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 careers@pharma.
com.
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.
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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.
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This type of fraud is normally perpetrated through fake websites, or through unsolicited e-mails claiming to be from the Company.
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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.
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The Talent Acquisition team corresponds from email addresses with the domain “@pharma.
com”.
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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 careers@pharma.
com.