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QC Supervisor (Weekend Shift: Fri.- Sun. 6:00AM - 6:30PM)

Purdue Pharma | Wilson, NC, US, 27893

Posted a day ago


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Description

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 QC Laboratory Supervisor will provide daily oversight of laboratory operations in the Quality Control department; including scheduling activities, overseeing training and providing input regarding team members overall job responsibilities including job proficiency and adherence to standard procedures and policies.


The Supervisor will oversee a team performing a variety of analyses, sampling and data review of: raw materials, investigational samples, process validation samples, method transfer samples, finished product release and stability samples, and microbiological samples in accordance with cGMP, GLP, DEA and company policies and procedures.


Additionally, the position is responsible for promoting and fostering a work environment that is safe and conducive to employee development and where Purdue's values are demonstrated and practiced.



Primary Responsibilities



  • Responsible to ensure all testing of raw material, microbiological, stability and release samples occur in a timely and organized manner and in accordance with cGMP, GLP, DEA and company policies and procedures.

  • Write, revise, develop, evaluate, and review Standard Operational Procedures. Focus on continuous improvement ensuring regulatory compliance and lab efficiency. Ensure data integrity and accurate documentation of all necessary and relevant information in a clear and concise manner as per cGMPs.

  • Identify areas of improvement and implement efficient solutions that increase compliance, data integrity, efficiency and reduce chance of errors.

  • Communicate openly within and between groups to provide and gather information, to optimize the use of resources and to optimize efficiency.

  • Provide training and assistance to Quality Control group members. Formulate development plan for group members and develop succession plan.

  • Oversee and actively participate in investigations, problem solving and troubleshooting for areas of responsibility.

  • Ensure that equipment and working areas are maintained with good safety and housekeeping practices. Assess equipment needs with regards to new technologies and capacity needs. Identify opportunities for out-sourcing of testing to optimize cost and efficiency.

  • Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.

  • Manage and maintain project timelines and provide leadership supporting method improvements and development/ validation activities. Perform data analyses and present findings and recommendations both verbally and in writing.

  • Work collaboratively in cross-functional teams to achieve goals and objectives relative to development programs and overall site compliance.

  • Review and author method validation /qualification/transfer documents in compliance with cGMP, ICH, USP, industry regulations, and company procedures. Author, review and approve operational and maintenance procedures relative to laboratory operations.

  • Improve and develop analytical methods primarily utilizing HPLC, GC, and Wet Chemical methods of analysis.

  • Interface and provide analytical support to manufacturing and development operations.

  • Provide technical support in testing and instrument setup, in troubleshooting methods, method improvement, method development and validation.

  • Reinforce proper compliance with cGMP, SOPs and FDA guidelines to maintain control requirements. Trouble shoot, identify problems, and make well informed decisions.

  • Communicate and motivate employees by making clear how their work objectives are directly linked to Purdue overall strategy. Also communicate strategic expectations throughout the organization and translate those expectations into specific work objectives.

  • Perform other related assignments and duties as required and assigned.



Education and Experience


A Bachelor's degree in biological, chemical, environmental, or related sciences from an accredited college or university.


A minimum of 5 years of pharmaceutical experience in a laboratory environment required (preferably in the area of solid oral dosage) and minimum 3 years of experience in a supervisory role.



Necessary Knowledge, Skills, and Abilities


Direct experience in a laboratory environment in solid oral dose (highly preferred).



  • Technical competence in analytical chemistry and/or microbiology.

  • HPLC, GC, Dissolution, Automation, Spectroscopy, UV/VIS, , and IR experience preferred.



  • Must have a comprehensive knowledge of cGMPs, DEA and FDA requirements.

  • Excellent verbal and written communication skills including technical writing.

  • Detail-oriented.

  • Strong analytical ability.

  • Experience in laboratory information management systems, chromatographic data systems, and Microsoft Office applications.

  • Ability to provide excellent customer service, manage others, and collaborate with lab personnel.

  • Ability to work independently under remote supervision.

  • Ability to adapt to a fast-changing work environment.

  • Ability to be flexible and change as business grows and changes.

  • Ability to work collaboratively as a team.

  • Ability to prioritize and meet deadlines.

  • Problem solving, solution oriented and production driven.



Supervisory Responsibilities (if Applicable)


Directly responsible for operative personnel in daily activities including all those required to meet production schedules. Reports to and seeks guidance as needed from the Operations management team.



Physical and 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, scanners, or other specialized equipment used in an office setting.

  • Ability to work a 12.5 hour per day/3-day work week, Friday - Sunday; 36 hours per week with overtime as required.



Manager Responsibilities (if applicable)


Chemists (Various levels and experiences)



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.


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 . 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 "".

  • 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 .


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