Document Control Jobs in Frederick, MD (NOW HIRING)

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Key Responsibilities:
Laboratory Operations & Testing

• Oversee daily operations and testing activities within the QC Microbiology Laboratory.
• Ensure timely and compliant execution of microbiological testing to support manufacturing and product release.
• Perform routine review and approval of test data, laboratory records, and associated documentation.
• Support the generation and review of Certificates of Analysis (CoAs) for product release.

Environmental Monitoring & Compliance

• Lead and sustain the site's Environmental Monitoring (EM) and Utilities Monitoring (UM) programs.
• Monitor environmental and utility data, identify trends, and communicate findings to management.
• Assemble reports and provide routine updates on environmental monitoring performance and compliance.
• Implement corrective and preventive actions when adverse trends or excursions are identified.
• Support optimization of the aseptic gowning qualification and training program.

Leadership & Team Development

• Supervise QC Microbiology staff and laboratory activities.
• Conduct performance evaluations, coaching, and regular employee development discussions.
• Maintain training programs and ensure ongoing qualification of QC Microbiology personnel.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

Investigations & Problem Solving

• Serve as Subject Matter Expert (SME) for EM and UM investigations.
• Lead or support investigations involving:
  • Environmental monitoring excursions
  • Utilities monitoring excursions
  • Out-of-Specification (OOS) results
  • Deviations associated with microbiological procedures
• Identify root causes and implement effective corrective and preventive actions (CAPAs).

Quality Systems & Documentation

• Develop, review, revise, and approve:
  • Standard Operating Procedures (SOPs)
  • Validation and qualification protocols
  • Validation and qualification reports
  • Controlled quality documentation
• Monitor GMP systems to ensure continued compliance with internal procedures and regulatory requirements.
• Review proposed changes to methods, procedures, systems, and regulatory submissions as needed.

Audits & Regulatory Support

• Support internal, customer, and regulatory inspections and audits.
• Ensure laboratory activities remain compliant with cGMP requirements and company quality standards.
• Represent the QC Microbiology function during cross-functional, site, and global meetings.

Continuous Improvement & Communication

• Collect and analyze departmental metrics to drive continuous improvement initiatives.
• Provide updates and key performance indicators during daily, weekly, and management meetings.
• Collaborate with Manufacturing, Quality Assurance, Validation, Facilities, and other functional groups to support site objectives.
• Perform additional responsibilities and special projects as assigned.

Preferred Qualifications:

• Bachelor's degree in Microbiology, Biology, Biochemistry, Life Sciences, or related scientific discipline with at least 5 years of experience in QC Microbiology within a pharmaceutical, biotechnology, cell therapy, or other GMP-regulated environment.
• Previous supervisory or leadership experience managing laboratory personnel.
• Strong experience with:
  • Environmental Monitoring (EM)
  • Utilities Monitoring (UM)
  • Aseptic processing and gowning qualification
  • OOS, deviation, and CAPA investigations
  • Product release support
• Working knowledge of FDA, EMA, and cGMP regulations.

Knowledge, Skills & Abilities:

• Strong understanding of microbiology laboratory operations within a cGMP environment.
• Expertise in environmental monitoring programs, data trending, and contamination control principles.
• Proven ability to lead investigations and perform root cause analysis.
• Excellent leadership, coaching, and employee development skills.
• Strong technical writing and documentation review capabilities.
• Effective verbal and written communication skills with the ability to interact across all levels of the organization.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Demonstrated commitment to quality, compliance, and continuous improvement.

The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
For jobs in the United States:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.