QC Scientist III - Technical Writer

Job Title:

QC Scientist III - Technical Writer Job Description The QC Scientist III - Technical Writer provides expert technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and client inquiries in support of commercial and clinical biopharmaceutical manufacturing. This role focuses on method validation and technical documentation while operating under cGMP, ICH, and global compendial guidelines. The position bridges Analytical Formulation Services and Quality Control, ensuring analytical methods are scientifically robust, compliant, and clearly documented. Responsibilities Provide technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and responses to client inquiries. Author, review, and maintain high-quality technical documents including protocols, validation reports, standard operating procedures (SOPs), and related cGMP documentation. Validate analytical methods developed by the Analytical Formulation Services team and prepare comprehensive validation reports that align with FDA, ICH, and

USP/EP/JP

guidelines. Serve as a key interface between Analytical Formulation Services and Quality Control during method transfer, qualification, and validation activities. Perform method risk assessments prior to validation activities and assist in optimizing method language and forms to ensure clarity and compliance. Advise on corrective and preventive action (CAPA) language to ensure alignment with analytical methods, SOPs, site policies, and scientific best practices. Collaborate cross-functionally to identify, develop, strengthen, and implement departmental policies and procedures that support compliant and efficient operations. Assist in technical training for analysts, data reviewers, and investigation writers, ensuring consistent understanding and execution of analytical methods and documentation standards. Participate in and provide technical support during FDA inspections, ISO and customer audits, and contribute to external audit response management for analytical topics. Attend new client meetings and on-site visits, maintaining high involvement with clients during method validation and transfer to build trust and ensure alignment on expectations. Manage critical reagent changes and review or approve internal reference material qualifications and recertifications to maintain analytical reliability. Expand scientific, technical, and compliance knowledge by reviewing relevant scientific literature, attending industry conferences, and completing appropriate training. Participate in continuous process improvement initiatives and support site safety initiatives to enhance quality, efficiency, and safe working practices. Perform other related duties as assigned to support the broader goals of the Quality Control and Analytical Formulation Services teams. Essential Skills Minimum of 3 years of

HPLC/UPLC

method validation experience in a quality, analytical, or pharmaceutical environment. Proven experience (3+ years) working in a GMP facility in a quality control role within the biopharmaceutical or pharmaceutical industry. Hands-on experience with HPLC and UPLC, including method validation using FDA guidelines. Strong working knowledge of cGMP principles and their application to analytical quality control. Experience applying ICH and USP compendial guidelines to analytical methods and documentation. Solid background in analytical chemistry and wet chemistry techniques. Technical competency with a wide range of analytical techniques such as capillary electrophoresis (cIEF/ICE, CE-SDS), UPLC/HPLC (excipient quantification, glycan analysis, proteolytic mapping, ion exchange chromatography, size-exclusion chromatography), ELISA, and cell-based assays for process impurities and potency assessments. Knowledge of US and international regulations and guidance (e.g., EU, ICH, GxP) applicable to clinical and commercial pharma/biopharma products. Outstanding technical reading and scientific writing skills, with the ability to create clear, concise, and compliant technical documents. Proficiency in MS Excel, MS PowerPoint, MS Teams, and MS Word for data analysis, reporting, and communication. Strong interpersonal skills, including active listening, conflict resolution, and the ability to influence diverse stakeholders. Ability to build strong, trust-based relationships with clients and internal partners. High level of organization, attention to detail, and proven time management skills with the ability to manage multiple projects simultaneously. Additional Skills & Qualifications Bachelor's degree in a biological science-related field, preferably Chemistry or Biochemistry. Familiarity with standard project management concepts, tools, and responsibilities, including defining objectives, scope, and expected results. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness within and across departments. Demonstrated commitment to ongoing professional development through reading scientific literature, attending conferences, and completing relevant training. Experience supporting inspections and audits (FDA, ISO, and customer) and contributing to audit responses for analytical issues. Comfort working in a client-facing role, including participation in new client meetings and on-site visits. Interest in long-term career growth, with the potential for conversion to a full-time role based on performance. Work Environment This is a full-time, Monday-Friday role with regular working hours, typically an 8-hour day (approximately 40 hours per week) with a flexible start time around 7:00-8:00 a.m. The position is primarily desk-based, with about 90% of time spent sitting in an office environment and approximately 10% standing or walking. Work takes place in a laboratory and office setting where personal protective equipment (PPE), including lab coats, gloves, eye protection, and safety shoes, is required as appropriate. The role involves potential exposure to fumes, chemicals, acids, and bases, and requires the ability to stand for extended periods when needed. The culture emphasizes meaningful work, continual learning, professional development, and access to substantial resources that support innovation and contributions to the broader scientific and healthcare community. Job Type & Location This is a Contract to Hire position based out of Berkeley, MO. Pay and Benefits The pay range for this position is $36.00 - $48.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Berkeley,MO.

Application Deadline This position is anticipated to close on May 1, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.