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ProCaps Labs

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Quality Control Method Development Specialist

The Quality Control Method Development Specialist is responsible for providing technical leadership for analytical method development, optimization, validation, verification, and transfer activities in support of ISO/IEC 17025 accreditation requirements, cGMP compliance, and laboratory quality system objectives. This position serves as the laboratory subject matter expert for analytical methodologies and instrumentation, including HPLC, GC, ICP-MS, HPTLC, UV/Vis, Protein Analyzer, and other laboratory technologies.

The Method Development Specialist supports implementation of new analytical technologies, leads technical aspects of laboratory investigations, develops and executes validation protocols, and collaborates with Quality Control Operations, Product Development, Quality Assurance, and other stakeholders to ensure analytical methods are scientifically sound, compliant, and fit for intended use.

This role is a key member of the Quality Control Compliance Team and plays a critical role in maintaining accreditation, reducing validation backlogs, improving data quality, and supporting continuous improvement initiatives.

Requirements

MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS

  • Bachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or another natural or physical science.
  • 3+ years of experience in analytical method development, validation, or laboratory quality control.
  • Demonstrated experience with analytical method development and validation.
  • Experience working in a regulated laboratory environment.
  • Strong understanding of analytical chemistry principles and laboratory investigations.
  • Proficiency with Microsoft Office applications.
  • Strong working knowledge and experience in HPLC, GC, ICP-MS, UV/VIS, HPTLC or similar laboratory instrumentation
  • Familiar with USP, AOAC, ICH, ISO/IEC 17025 and other analytical method development bodies

OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

  • Develop, optimize, implement, and troubleshoot analytical methods for raw materials, in-process materials, finished products, stability programs, and new product formulations.
  • Adapt USP, AOAC, customer, regulatory, and published methods for existing laboratory instrumentation and applications.
  • Design and execute method validation, verification, transfer, equivalency, and performance studies.
  • Prepare validation protocols, reports, technical assessments, and supporting documentation while maintaining validation master plans and roadmaps.
  • Establish scientifically justified acceptance criteria and validation parameters.
  • Lead the implementation, qualification, verification, and integration of new analytical instrumentation and technologies.
  • Develop methodologies and procedures for emerging technologies, including HPTLC and Protein Analyzer platforms.
  • Identify and implement opportunities to improve testing efficiency, accuracy, throughput, and automation.
  • Serve as the laboratory subject matter expert for analytical methods, instrumentation, data interpretation, and technical troubleshooting.
  • Provide technical support, training, competency development, mentoring, and problem-solving guidance to laboratory personnel.
  • Lead technical assessments and investigations related to OOS, OOT, atypical results, and laboratory nonconformances.
  • Support root cause analyses, CAPA development, analytical data reviews, trend evaluations, and continuous method improvement.
  • Ensure method development, validation, and laboratory activities comply with ISO/IEC 17025, cGMP, data integrity, and applicable regulatory requirements.
  • Support audits, accreditation assessments, regulatory inspections, internal audits, and maintain audit-ready documentation.
  • Drive quality system improvements by reducing validation backlogs, improving laboratory performance metrics, enhancing method robustness and efficiency, supporting timely investigations, and contributing to continuous audit readiness and compliance.

WORK ENVIRONMENT

  • Work is performed primarily in a smoke-free laboratory and office environment.
  • Exposure to chemicals, laboratory equipment, and production areas may occur.
  • Appropriate personal protective equipment (PPE) must be worn when required.

PHYSICAL REQUIREMENTS

  • Frequent sitting, standing, walking, and climbing
  • Able to lift up to 25 lbs.

Benefits

ProCaps provides :

    • A competitive salary!
    • Top-Tier Medical, Dental & Vision Coverage - $0 when you qualify for the Wellness Program!
    • Paid Time Off, Eight (8) Company Holidays
    • 401(k) with Company Match – up to 4.5%
    • 100% Company Life Coverage
    • 100% Short Term Disability Coverage
    • Gym Membership Reimbursement
    • Vitamin Allowance + Discounts
    • Company-Funded Health Savings Account ($1,600/year)
    • Cash Reward Employee Referral Program
    • Pet Insurance

*** Fantastic work environment that focuses on Safety, Quality, Community, and amazing people. We hire top talent and celebrate the ingenuity and tenacity of our team members and leaders!

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What this application asks

workable

First name, Last name, Email, Phone, Address, Resume, Experience, Education, How would you like us to get in touch?, Please include your preferred shift or time of day, and note any limitations we should be aware of:, What are your salary expectations for this role?, What do you know about ProCaps Laboratories, and what excites you most about the opportunity to join our team?, ProCaps Laboratories operates in an environment where certain food allergens may be present including but are not limited to: MILK, EGGS, FISH, CRUSTACEAN SHELLFISH, TREE NUTS, PEANUTS, WHEAT, SOYBEANS, and SESAME. Many of our roles may involve exposure to one or more of these substances. Due to the nature of our manufacturing environment, complete elimination of allergen exposure CANNOT be guaranteed. Are you able to perform the essential functions of this job, with or without reasonable accommodation?, Have you previously worked at ProCaps Laboratories as a Regular Employee, a Consultant, or through a Staffing Agency? If yes, please state dates of employment, position held, and name of Staffing Agency (if applicable):, Do you have any friend(s) and/or relative(s) currently working at ProCaps Laboratories? If yes, please provide the name(s)., Are you referred by a current ProCaps employee? Is YES, please list the employee name(s)., We’d love to connect! If you have a LinkedIn profile, drop the link below so we can learn more about you

  • This role requires a Bachelor’s Degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or another natural or physical science and 3+ years of experience in analytical method development, validation, or laboratory quality control. Do you meet those requirements? written answer
  • Describe your experience developing, optimizing, and validating analytical methods in a regulated laboratory environment. Please provide a specific example involving an instrument such as HPLC, GC, ICP-MS, UV/VIS, or HPTLC, and explain your role, the validation approach you used, and how you addressed any challenges or failures encountered. written answer
  • Describe a situation where you led or significantly contributed to an analytical laboratory investigation, such as an OOS, OOT, atypical result, or method-related nonconformance. How did you determine the root cause, what corrective actions did you recommend or implement, and how did you ensure compliance with applicable requirements such as cGMP, USP, ICH, or ISO/IEC 17025? written answer
  • Location & Commute: Please select the option that best describes your current situation. This role prefers someone who is willing to work ONSITE. choose any
  • *Please select the option that best describes your current work authorization status in the United States. NOTE: This information is collected only to assess employment eligibility. ProCaps Laboratories does not discriminate on the basis of citizenship, immigration status, or national origin. choose one
  • *By submitting this application, you acknowledge and consent to this process if selected for further consideration. NOTE : ProCaps Laboratories conducts a thorough background check as part of the hiring process. A conviction will not automatically disqualify you from employment. We consider the nature of the offense, the time elapsed, and its relevance to the position. Have you ever been convicted of a felony or serious misdemeanor? If yes, please briefly explain (OPTIONAL). written answer
  • ProCaps Labs participates in E-Verify, a system used to verify employment eligibility. If hired, will you be able to provide valid/unexpired documents to complete the E-Verify process? yes / no
  • PLEASE READ THE FOLLOWING CAREFULLY : I certify that all information provided in this application is true and complete to the best of my knowledge. I understand that any false statement, misrepresentation, or omission may result in disqualification from consideration or, if employed, immediate termination. I understand that submitting this application does not guarantee employment and does not create a contract or promise of future employment with ProCaps Laboratories. I also understand that, if offered employment, my position will be subject to the company’s policies, including background checks, eligibility verification, and compliance with all job-related requirements. Do you acknowledge and agree to this statement? ☐ Yes ☐ No yes / no

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