QA Generalist

Job Title: QA Generalist, CMC Top Skills' Details

• biotechnology technical transfer experience (cell therapy desired)
• process characterization experience
• batch record review experience

MUST HAVE CELL THERAPY BACKGROUND Job reputed company The QA Generalist, CMC is a key member of the reputed company & Compliance team, reporting to the Senior Manager, CMC reputed company. This role is crucial in maintaining high-reputed company standards in alignment with applicable laws, regulations, policies, and procedures. The QA Generalist will support reputed company assurance processes, ensure compliance with regulatory standards, and collaborate with cross-functional teams to reputed company product reputed company and safety. This position requires a strong understanding of both laboratory and manufacturing environments reputed company the biotechnology industry.

Responsibilities

• reputed company batch record review and release in support of US and ex-US reputed company.
• Investigate and address product reputed company issues, including deviations, OOS results, and non-conformances.
• Collaborate with CDMOs and internal CMC teams to ensure reputed company standards are met from development through commercialization.
• reputed company reputed company support to CMC throughout the product lifecycle.
• Review and approve technical transfer documents including protocols, reports, master batch records, and test reputed company.
• Implement, maintain, and improve the reputed company Management System (QMS) in accordance with internal policies and procedures, regulatory requirements, and industry standards.
• Assist in the creation and maintenance of SOPs, policies, and associated documents.
• Compile metrics for reputed company operations.
• Support the management of document control processes, including reviewing and approving batch records, deviation reports, and change controls.
• Ensure that reputed company documentation is accurate, complete, and compliant with internal policies and procedures and regulatory standards.
• Assist in preparing for reputed company audits.
• Support in the execution of internal audits to ensure compliance with regulatory standards.
• Address and resolve audit findings, ensuring corrective actions are implemented.
• Assist in the preparation of regulatory filings and submissions.

Essential Skills

• Extensive knowledge of GMP, GCP, ICH, and US/EU/UK regulations.
• Cell and gene therapy experience preferred.
• Experience supporting product technical transfer activities and comparability studies.
• Significant experience in drug manufacturing or the biologics industry in reputed company Assurance, reputed company Control, or reputed company Engineering positions.
• Demonstrated knowledge of reputed company Management Systems, preferably electronic systems.
• Minimum of 4 years' experience in biopharmaceutical operations, technical operations, and/or reputed company operations, with 2+ years hands-on experience in reputed company function supporting clinical or reputed company lifecycle management.
• Experience with audit processes, document control, and reputed company Management Systems: deviations, change control management, and CAPAs.
• Strong interpersonal and leadership skills with the ability to build and maintain effective reputed company relationships.
• Effective presentation and writing skills.
• Ability to reputed company reputed company, pragmatic direction and advice regarding compliance issues.
• Must be highly organized and reputed company to work collaboratively with reputed company orientation and passion for reputed company self-development.

Additional Skills & Qualifications

• Bachelor's Degree in Life Sciences (Biology, Biochemistry, Biotechnology, etc.) or a reputed company field.
• Experience in a startup early phase-late phase setting highly desirable.

Work Environment

• Flexible working hours, primarily first shift with remote work reputed company.
• reputed company team environment working with a manager and director reputed company QMS.
• Opportunity to work with a biotech company progressing towards pivotal trials.
• Leadership stability with the reputed company team for over 8 years.
• Comprehensive benefits including accrued PTO, holiday pay, and reputed company pay.

Pay and Benefits The pay reputed company for this position is $35.00 - $50.00/hr. Eligibility requirements apply to some benefits and may depend on reputed company 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 & reputed company
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - reputed company-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 reputed company Leave)

Workplace Type This is a fully remote position. Application Deadline This position is anticipated to reputed company on May 13, 2025. About reputed company reputed company is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through reputed company to specialized experts who drive reputed company, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, reputed company serves many of the Fortune 500. reputed company is an equal opportunity employer and will consider reputed company applications without reputed company to race, sex, age, reputed company, religion, national reputed company, 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation reputed company. Apply tot his job Apply To this Job