New Jersey Staffing
Analytical Data Reviewer
As an Analytical Data Reviewer, you will be responsible for developing and maintaining essential documentation related to Quality Control and Analytical Development. Your role will ensure compliance with regulatory guidelines, support collaborative efforts, and contribute to continuous improvement initiatives within the laboratory. Responsibilities include writing, editing, and maintaining Standard Operating Procedures (SOPs), test methods, specifications, work instructions, and protocols related to Quality Control and Analytical Development. You will also develop and update analytical test reports, validation protocols, and stability study reports. Additionally, you will prepare method validation protocols, method transfer protocols, technical documents, including change controls, deviations, CAPAs, and OOS (Out of Specification) and laboratory investigations. Ensuring consistency, clarity, and compliance in all documentation is crucial. You will maintain up-to-date copies of all cGMP documents in the laboratory and relevant databases. You will assist in preparing documentation for regulatory submissions and audits, maintain accurate version control and document tracking within electronic document management systems, and work closely with QC analysts, outside contract testing laboratories, customers, equipment manufacturers, and Quality Assurance to gather technical information. You will also assist in reviewing and updating documents based on feedback from Quality Assurance and Customers, provide guidance to QC personnel on documentation best practices, develop training materials for QC team members, and support quality improvement initiatives by identifying gaps in documentation and recommending improvements. Staying up to date with industry best practices, regulatory changes, and advancements in pharmaceutical quality control is essential. Essential Skills include 4-5 years of bench experience as a chemist, proficiency in HPLC Dissolution, KF Wet Chemistry, Sample preparation, experience with Solid Oral Dosage and Empower Software, ability to identify non-conformance in laboratory settings, strong understanding of analytical techniques and laboratory procedures, and familiarity with regulatory guidelines such as FDA, ICH, USP, EP, cGMP, and GLP. Additional Skills & Qualifications include a Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Microbiology, Biotechnology, or a related field, 2-5 years of experience in technical writing within the pharmaceutical or biotech industry, preferably in Quality Control/Analytical Development, excellent writing, editing, and organizational skills, proficiency in Microsoft Office Suite, strong attention to detail, and ability to work independently and collaborate effectively with cross-functional teams. The role is based in a laboratory setting with a team of 10 people. The facility is new, offering a dynamic and growing environment. High pay and opportunities within a growing Contract Manufacturing Organization (CMO) make this role attractive. The pay range for this position is $40.00 - $42.00/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). This is a fully onsite position in East Windsor, NJ. The application deadline is anticipated to close on Aug 15, 2025. Actalent is a global leader in engineering and sciences services and talent solutions. 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.
As an Analytical Data Reviewer, you will be responsible for developing and maintaining essential documentation related to Quality Control and Analytical Development. Your role will ensure compliance with regulatory guidelines, support collaborative efforts, and contribute to continuous improvement initiatives within the laboratory. Responsibilities include writing, editing, and maintaining Standard Operating Procedures (SOPs), test methods, specifications, work instructions, and protocols related to Quality Control and Analytical Development. You will also develop and update analytical test reports, validation protocols, and stability study reports. Additionally, you will prepare method validation protocols, method transfer protocols, technical documents, including change controls, deviations, CAPAs, and OOS (Out of Specification) and laboratory investigations. Ensuring consistency, clarity, and compliance in all documentation is crucial. You will maintain up-to-date copies of all cGMP documents in the laboratory and relevant databases. You will assist in preparing documentation for regulatory submissions and audits, maintain accurate version control and document tracking within electronic document management systems, and work closely with QC analysts, outside contract testing laboratories, customers, equipment manufacturers, and Quality Assurance to gather technical information. You will also assist in reviewing and updating documents based on feedback from Quality Assurance and Customers, provide guidance to QC personnel on documentation best practices, develop training materials for QC team members, and support quality improvement initiatives by identifying gaps in documentation and recommending improvements. Staying up to date with industry best practices, regulatory changes, and advancements in pharmaceutical quality control is essential. Essential Skills include 4-5 years of bench experience as a chemist, proficiency in HPLC Dissolution, KF Wet Chemistry, Sample preparation, experience with Solid Oral Dosage and Empower Software, ability to identify non-conformance in laboratory settings, strong understanding of analytical techniques and laboratory procedures, and familiarity with regulatory guidelines such as FDA, ICH, USP, EP, cGMP, and GLP. Additional Skills & Qualifications include a Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Microbiology, Biotechnology, or a related field, 2-5 years of experience in technical writing within the pharmaceutical or biotech industry, preferably in Quality Control/Analytical Development, excellent writing, editing, and organizational skills, proficiency in Microsoft Office Suite, strong attention to detail, and ability to work independently and collaborate effectively with cross-functional teams. The role is based in a laboratory setting with a team of 10 people. The facility is new, offering a dynamic and growing environment. High pay and opportunities within a growing Contract Manufacturing Organization (CMO) make this role attractive. The pay range for this position is $40.00 - $42.00/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). This is a fully onsite position in East Windsor, NJ. The application deadline is anticipated to close on Aug 15, 2025. Actalent is a global leader in engineering and sciences services and talent solutions. 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.