Chemist

Job Description

Job Description

Quality Control Chemist

Job Description

This position offers an experienced Quality Control Chemist the opportunity to support analytical testing, method validation, and regulatory compliance within a highly regulated pharmaceutical manufacturing environment. The chemist ensures the quality and timely release of raw materials, in-process materials, packaging components, and finished products while maintaining strict adherence to cGMP, GLP, FDA regulations, and data integrity requirements. The role contributes directly to product quality, patient safety, and continuous improvement initiatives across the laboratory and manufacturing operations.

Responsibilities

• Perform analytical testing of raw materials, packaging materials, in-process samples, finished products, and utility systems using appropriate validated methods.
• Develop, review, and maintain specifications, test methods, standard operating procedures (SOPs), and other laboratory documentation in compliance with regulatory and internal quality standards.
• Conduct method validations, method transfers, and method suitability studies to ensure robustness, accuracy, and reproducibility of analytical procedures.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results, identify root causes, and support the implementation of deviations, corrective and preventive actions (CAPAs), change controls, and quality risk assessments.
• Review analytical data for completeness, accuracy, and compliance, and approve Certificates of Analysis (COAs) for materials and finished products.
• Manage laboratory equipment qualification, calibration, maintenance, and associated documentation, including support for IQ/OQ/PQ activities where applicable.
• Ensure laboratory instruments such as HPLC, GC, FTIR, UV-Vis, and Karl Fischer titrators operate within validated parameters and remain in a state of control.
• Support internal, customer, and regulatory audits by providing documentation, explaining laboratory practices, and maintaining continuous inspection readiness.
• Ensure strict compliance with data integrity principles, cGMP, GLP, USP, ICH guidelines, FDA regulations, and laboratory best practices in all testing and documentation activities.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to support product release and resolve quality issues.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance laboratory efficiency, method performance, and overall quality systems.
• Prepare clear, accurate technical documentation and reports related to analytical results, investigations, validations, and equipment qualifications.

Essential Skills

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Microbiology, or a related scientific field.
• At least 5 years of Quality Control experience in the pharmaceutical industry.
• Experience supporting sterile injectable manufacturing environments.
• Hands-on experience operating and troubleshooting HPLC, GC, FTIR, UV-Vis, Karl Fisher, and other analytical instrumentation.
• Strong knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), FDA regulations, USP and ICH guidelines, and data integrity requirements.
• Proven ability to perform and interpret analytical testing on raw materials, in-process samples, packaging components, and finished products.
• Experience reviewing analytical data and approving Certificates of Analysis (COAs) in a regulated environment.
• Demonstrated capability to investigate OOS/OOT results and support deviations, CAPAs, change controls, and quality risk assessments.
• Competence in managing laboratory equipment qualification, calibration, maintenance, and related documentation.
• Ability to maintain inspection readiness and support internal, customer, and regulatory audits.

Additional Skills & Qualifications

• Experience with method validation, including development and execution of validation protocols and reports.
• Experience with equipment qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience in conducting laboratory investigations and documenting findings in a clear and compliant manner.
• Familiarity with Laboratory Information Management Systems (LIMS) and electronic laboratory systems.
• Strong technical writing skills for drafting SOPs, test methods, validation documents, and investigation reports.
• Effective problem-solving skills with the ability to identify root causes and propose practical corrective and preventive actions.
• Strong verbal and written communication skills for collaborating with cross-functional teams and presenting information during audits.
• Attention to detail and a quality-focused mindset suited to a highly regulated pharmaceutical environment.

Work Environment

The role is based in a GMP clean room environment within a pharmaceutical manufacturing facility, where the chemist works primarily in a Quality Control laboratory. The position involves routine use of advanced analytical technologies and instrumentation, including HPLC, GC, FTIR, UV-Vis spectrophotometers, Karl Fisher titrators, and electronic laboratory systems such as LIMS. Work is performed under strict cGMP and GLP conditions with a strong emphasis on data integrity, documentation accuracy, and compliance with USP, ICH, and FDA guidelines. The environment requires adherence to clean room protocols and controlled procedures to support sterile injectable manufacturing, fostering a culture of quality, safety, and continuous improvement.

This is a Contract to Hire position based out of Boca Raton, FL.

The pay range for this position is $40.87 - $55.29/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)

This is a fully onsite position in Boca Raton,FL.

This position is anticipated to close on Aug 24, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.