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Job Description Position Summary – The Quality Control Raw Materials Chemist I performs testing using a variety of analytical techniques. The successful candidate ensures that Testing and Documentation is compliant with GMP regulations and internal procedures The ideal candidate will additionally possess superior communication skills. The position will be operating within a GMP environment for a Quality Control CDMO. Essential Functions • Perform testing of raw materials, packaging components, and other samples., • Well versed with various laboratory techniques, including, but not limited to HPLC, GC, titrations, and various raw materials testing techniques., • Conduct routine analytical experiments using established analytical methods and procedures., • Data entry into reports, as directed by senior laboratory personnel., • Verify simple transcription processes, such as checking accuracy of calculations and reviewing daily equipment verifications for compliance., • Support testing for investigations for OOS, OOT, and aberrant results and troubleshooting., • Review and maintain laboratory notebooks., • Ensure data collected is processed and submitted for review in a timely manner., • Maintains laboratory inventory of chemicals, standards, and consumables and orders materials as necessary., • Aid in investigations for OOS, OOT, and aberrant results and troubleshooting by assisting in root cause determination., • Generate and/or review shipping paperwork for third party testing and prepare samples for shipment., • Create purchase requisitions for lab supplies and third-party testing, • Perform weekly laboratory audit inspections, • Perform sampling of raw materials as needed, • Other duties as assigned Supervisory responsibilities: • Direct Reports: None, • Indirect Reports: None Key Relationships: • Manufacturing Operations, • Quality Assurance, • Analytical R&D, • Program Management Travel requirements: • None Education and Experience • Minimum BA or BS in a scientific discipline required, • Minimum 2 – 4 years in a Quality Control setting for Raw Materials Knowledge, Skills, and Abilities • Knowledge of cGMPs, • Good communication, organization and computer skills are required., • Knowledge of Empower and Microsoft Office (Excel, Word) is required; LIMS knowledge is desired., • Ability and willingness to work additional hours as required by business needs, • Experience with testing per USP, EP, BP, and JP monographs., • Ability to interpret various compendial guidelines to ensure specifications meet regulatory requirements., • Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators, Coulometric Karl Fischer Titrators, Melting Point Apparatus, Muffle Furnace, UV-Vis, Refractometers, and Particle size., • Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders, • Ability to work with modest supervision, • Able to multi-task productively, applying time management processes and procedures effectively., • Self-directed Physical Demands and Work Environment While performing the duties of this job, there may be certain physical demands required for the position. • Requires constant standing, walking, seeing, gripping, & hearing, • Requires frequent sitting, bending, pushing, & reaching, • Requires constant carrying under 20 LBS, occasionally 20 – 60 LBS., • Requires frequent lifting & pulling under 20 LBS, occasionally 20 – 60 LBS., • Requires occasional twisting Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked. Powered by JazzHR V5qtfE57G1

Job DescriptionPosition Summary – The QC Chemist II position performs testing using a variety of analytical techniques. The successful candidate ensures that Testing and Documentation is compliant with GMP regulations and internal procedures. The position will be operating within a GMP environment for an Analytical QC team in a CDMO. Essential Functions • Well versed with various laboratory techniques, including, but not limited to HPLC, GC, titrations, and various wet chemistry techniques., • Carry out routine laboratory work as directed by management and/or senior laboratory personnel with minimal supervision, • Performs complex analyses with moderate supervision., • Conduct routine analytical experiments using established analytical methods and procedures., • Data entry into reports, as directed by senior laboratory personnel., • Verify simple transcription processes, such as checking accuracy of calculations and reviewing daily equipment verifications for compliance., • Support testing for investigations for OOS, OOT, and aberrant results and troubleshooting., • Review and maintain laboratory notebooks., • Ensure data collected is processed and submitted for review in a timely manner., • Aid in investigations for OOS, OOT, and aberrant results and troubleshooting by assisting in root cause determination and report writing., • Maintains laboratory inventory of chemicals, standards, and consumables and orders materials as necessary., • Revises existing methods, SOPs, and Work Instructions as needed. Supervisory responsibilities: • Direct Reports: None, • Indirect Reports: None Key Relationships: • Manufacturing Operations, • Analytical R&D, • Quality Assurance Travel requirements: • N/A Education and Experience • B.S with 4-6 years' experience, or M.S with 3-4 years of experience: focus in chemistry, pharmaceutics or related scientific discipline, • 2-5 years´ experience in a GMP laboratory setting in the pharmaceutical industry, • Must have experience with general laboratory instruments, such as FTIR, Particle Size, Titration Equipment, and UV-Vis, • Must have experience in HPLC testing and troubleshooting, • Must have prior experience with raw materials or finished products testing in a GMP pharmaceutical environment., • Must be well versed with Good Documentation Practices and ALCOA++ principles., • Technical report writing proficiency preferred Knowledge, Skills, and Abilities • Proficiency in Empower, MS Excel, and MS Word, • Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience, • Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical and has a right first-time mentality Physical Demands and Work Environment While performing the duties of this job, there may be certain physical demands required for the position. • Requires constant standing, walking, seeing, gripping, & hearing, • Requires frequent sitting, bending, pushing, & reaching, • Requires occasional carrying under 20 LBS., • Requires frequent lifting & pulling under 20 LBS, occasionally 20 – 60 LBS., • Requires occasional twisting Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked. Limitations and Disclaimer The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Powered by JazzHR aS9ej4lZQI

Job Description Position Summary – The Chemist III/Sr. Chemist Raw Materials ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients Essential Functions • Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines., • Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks., • Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements, • Interact with third party laboratories for microbial and analytical testing of raw materials, • Generate and/or review shipping paperwork for third part testing and prepare samples for shipment., • Create purchase requisitions for lab supplies and third-party testing, • Perform weekly laboratory audit inspections, • Perform sampling of raw materials as needed, • Review third party laboratory investigations and protocols., • Execute intermediate to advanced chemical and instrumental testing of raw materials using HPLC, GC, FTIR, UV-Vis, Karl Fischer titration, and wet chemistry., • Ensure all testing meets compendial standards (USP/EP/JP) and regulatory expectations. Conduct peer reviews of data, Certificates of Analysis (COAs), and laboratory logbooks., • Author and review GMP documentation including Standard Operating Procedures (SOPs), protocols, deviations, Corrective and Preventive Actions (CAPAs), and change controls., • Provide technical guidance to junior analysts. Lead method verification, validation, and method transfer activities for incoming raw materials., • Oversee the calibration, maintenance, and troubleshooting of laboratory equipment., • Other duties as assigned Supervisory responsibilities • Direct Reports: No, • Indirect Reports: None Key Relationships • Manufacturing Operations, • Quality Assurance, • Analytical R&D, • Program Management Travel requirements: • None Education and Experience • Minimum BA or BS in a scientific discipline required, • Minimum 5-8 years of Analytical chemistry experience with a cGMP/GLP environment, preferably at a CDMO or pharmaceutical company. Knowledge, Skills, and Abilities • Knowledge of cGMPs, • Good communication, organization and computer skills are required., • Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired., • Ability and willingness to work additional hours as required by business need, • At least 5 years’ experience in a CRO environment, • Experience with USP, EP and JP monographs., • Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size., • Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders, • Excellent verbal and written communication skills, • Ability to work with minimal supervision, • Experience in Data Review of Analytical data per GDP guidelines., • Proven ability to review and evaluate the compliance and completeness of analytical data., • Able to multi-task productively, applying time management processes and procedures effectively., • Works toward common goals by supporting, encouraging, and sharing information with colleagues., • Strong analytical skills and ability to understand business and financial implications of contracts, • Self-directed Physical Demands and Work Environment While performing the duties of this job, there may be certain physical demands required for the position. • Requires frequent sitting and walking, • Requires carrying under 20 LBS, occasionally 20 – 60 LBS, • Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS, • Requires occasional bending, twisting, reaching, & gripping, • Requires constant seeing & hearing Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked. Limitations and Disclaimer The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Powered by JazzHR 9s721DUGQ2

MedPharm in Durham, NC seeks a Quality Control Raw Materials Chemist I to perform testing in a GMP environment.

Job Overview QC Chemist C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Education & Experience BS or MS in Chemistry or Pharmaceutical Sciences, or related field.

Aurolife is seeking a Chemist B to ensure products and materials meet quality standards and regulatory requirements.

Job Overview Chemist B is responsible for ensuring that products and materials meet established quality standards and regulatory requirements by conducting laboratory tests, analyzing results, and maintaining accurate documentation. Knowledge in USP/ICH/FDA Ability to learn quickly and decision mak

MedPharm Ltd in Durham, NC seeks a Quality Control Raw Materials Chemist I to perform testing using HPLC, GC, and titration techniques in a GMP environment.

Aurolife is seeking a QC Chemist C to perform a range of analytical tests to assess strength, identity and purity of samples within the stability team.

Job Overview QC Chemist C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The Chemist C will be responsible for review of analytical documents, investigations, maintaining GLP status in lab. Education & Experience BS or MS in Chemis

A pharmaceutical company in North Carolina seeks a QC Chemist III to ensure compliance in the testing and documentation of raw materials.

Qualifications Bachelor’s degree in Chemistry, Biochemistry, or related field.

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