Sr. Quality Specialist I, Chemist (On-site)
Purdue Pharma, Raleigh, NC, United States
Job Summary
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. May 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. May participate in equipment validation IQs, OQs, PQs, and MQs, if necessary. Provide assistance and technical support to other analysts with chemical testing needs and perform troubleshooting of analytical methods and instrumentation. May be responsible for technical supervision of Quality colleagues and serve as back‑up to management to ensure smooth and efficient operation of the lab.
Primary Responsibilities
Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
Operate and maintain all analytical instrumentation and equipment as per established procedures.
Write, revise, develop and evaluate operational and maintenance procedures.
Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
Provide training and assistance to other group members.
Actively participate in investigations, problem solving, and troubleshooting.
Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
Re‑stock chemicals and consumables used in analysis.
Prepare and present data summaries (written and oral) as necessary.
Exercise good judgment in interpreting, understanding context, and reporting data.
Proactively identify potential problems and recommend solutions.
Prepare, write, and distribute reports as appropriate.
Participate in preparation and revision of job‑related controlled documents.
Perform analytical testing of samples under limited direction.
Support the creation, revision and development of test methods, operational and maintenance procedures, and other job‑related controlled documents.
Evaluate accuracy, completeness, and adequacy of reports.
Independently prioritizes workload.
Require minimal guidance and supervision when conducting routine and non‑routine activities in primary discipline.
Comply with site and regulatory controlled substance documentation and accountability procedures while maintaining high level to diversion possibilities.
May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
Perform other related assignments and duties as required and assigned.
Education and Experience
The incumbent must have a BA or BS degree in Chemistry or closely related science with six years minimum laboratory experience in pharmaceutical or related industries; or a graduate degree (MS Preferred) with 4‑7 years’ experience. Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.
Necessary Knowledge, Skills, and Abilities
Must demonstrate sound comprehension of multiple analytical technologies (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, Raman, or IR); and must have a comprehensive knowledge of cGMPs and FDA requirements as well as familiarity with USP and EP monographs.
Problem Solving
Effectively identify, describe, and communicate problems and impact in a timely manner.
Routinely participate in problem resolution.
Identify, track, and resolve issues to closure.
Proactively identify potential problems and recommend possible solutions.
Data Analysis/Reporting
Evaluate accuracy, completeness, and adequacy of reports.
Author, revise and annotate job‑related controlled documents.
Leadership Competencies
May train Quality colleagues in processes and procedures.
May be responsible for technical supervision of Quality colleagues. This may include:
Assigning work
Day‑to‑day supervision
Input to performance evaluation
Participating in hiring process
Organize and coordinate activities for assigned projects anticipating future needs.
Supervisory Responsibilities (if Applicable)
The Sr. Quality Specialist I (Chemist) reports to the Manager/Senior Manager. Sr. Quality Specialist I may coach/ mentor junior staff including temporary staff and interns.
Physical and Environmental
Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
Lift and maneuver equipment and materials weighing up to 20 pounds.
Use small hand and power tools to perform incidental maintenance.
Perform cleaning and assembly/disassembly on laboratory equipment that may require pulling, pushing, or twisting to remove equipment shields, parts, and panels.
Must possess the ability to detect, recognize, and accurately distinguish defects such as discoloration, particulate matter, and other visual anomalies at close range (18 inches) with or without a reasonable accommodation (magnifiers, prescription glasses).
Ability to work a 10‑hour per day/4‑day work week; 40 hours per week with overtime as required.
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.
Equal Employment Opportunity
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.
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)
Legal Information
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.
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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. May 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. May participate in equipment validation IQs, OQs, PQs, and MQs, if necessary. Provide assistance and technical support to other analysts with chemical testing needs and perform troubleshooting of analytical methods and instrumentation. May be responsible for technical supervision of Quality colleagues and serve as back‑up to management to ensure smooth and efficient operation of the lab.
Primary Responsibilities
Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
Operate and maintain all analytical instrumentation and equipment as per established procedures.
Write, revise, develop and evaluate operational and maintenance procedures.
Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
Provide training and assistance to other group members.
Actively participate in investigations, problem solving, and troubleshooting.
Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
Re‑stock chemicals and consumables used in analysis.
Prepare and present data summaries (written and oral) as necessary.
Exercise good judgment in interpreting, understanding context, and reporting data.
Proactively identify potential problems and recommend solutions.
Prepare, write, and distribute reports as appropriate.
Participate in preparation and revision of job‑related controlled documents.
Perform analytical testing of samples under limited direction.
Support the creation, revision and development of test methods, operational and maintenance procedures, and other job‑related controlled documents.
Evaluate accuracy, completeness, and adequacy of reports.
Independently prioritizes workload.
Require minimal guidance and supervision when conducting routine and non‑routine activities in primary discipline.
Comply with site and regulatory controlled substance documentation and accountability procedures while maintaining high level to diversion possibilities.
May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
Perform other related assignments and duties as required and assigned.
Education and Experience
The incumbent must have a BA or BS degree in Chemistry or closely related science with six years minimum laboratory experience in pharmaceutical or related industries; or a graduate degree (MS Preferred) with 4‑7 years’ experience. Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.
Necessary Knowledge, Skills, and Abilities
Must demonstrate sound comprehension of multiple analytical technologies (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, Raman, or IR); and must have a comprehensive knowledge of cGMPs and FDA requirements as well as familiarity with USP and EP monographs.
Problem Solving
Effectively identify, describe, and communicate problems and impact in a timely manner.
Routinely participate in problem resolution.
Identify, track, and resolve issues to closure.
Proactively identify potential problems and recommend possible solutions.
Data Analysis/Reporting
Evaluate accuracy, completeness, and adequacy of reports.
Author, revise and annotate job‑related controlled documents.
Leadership Competencies
May train Quality colleagues in processes and procedures.
May be responsible for technical supervision of Quality colleagues. This may include:
Assigning work
Day‑to‑day supervision
Input to performance evaluation
Participating in hiring process
Organize and coordinate activities for assigned projects anticipating future needs.
Supervisory Responsibilities (if Applicable)
The Sr. Quality Specialist I (Chemist) reports to the Manager/Senior Manager. Sr. Quality Specialist I may coach/ mentor junior staff including temporary staff and interns.
Physical and Environmental
Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
Lift and maneuver equipment and materials weighing up to 20 pounds.
Use small hand and power tools to perform incidental maintenance.
Perform cleaning and assembly/disassembly on laboratory equipment that may require pulling, pushing, or twisting to remove equipment shields, parts, and panels.
Must possess the ability to detect, recognize, and accurately distinguish defects such as discoloration, particulate matter, and other visual anomalies at close range (18 inches) with or without a reasonable accommodation (magnifiers, prescription glasses).
Ability to work a 10‑hour per day/4‑day work week; 40 hours per week with overtime as required.
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.
Equal Employment Opportunity
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.
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)
Legal Information
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.
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