QA Project Leader (Microbiology Sterility Assurance)

Job Summary Salary Range: $90,000 to $110,000

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

Responsibilities

Collaborates with the Sr. Director, Quality Assurance to provide project management for compliance topics and continuous improvement program management to support the company's short- and long-term goals for maintaining quality systems, compliance, and efficiency. This includes direct oversight for the evaluation, implementation, execution, and follow-up on quality systems and metrics in support of GMP compliance and release of finished product. This includes oversight for the final review of investigation to ensure product quality, and appropriate implementation of corrective actions in a timely manner to prevent recurrence.

Job Responsibilities:

• Serve as a change agent performing project management duties (PMO).
• Manage projects independently while focusing on providing the most impact by coordinating and overseeing projects led by various QA and operations team.
• Perform PMO duties by tracking progress, ensuring project plans have clear deliverables, deadlines, and responsibilities.
• Provide progress reports, assist in removing barriers, and escalate issues when additional support is needed.
• Manage projects that primarily focus on compliance or continuous improvement / simplification category.
• Key areas of impact in the plant are deviation reduction, improvements in batch right the first time (BRFT) and batch release cycle time (also known as CRT).
• Additional areas of impact include reduction of full and partial rejects, yield improvement, complaint reduction, deviation reduction, and CAPAs project management.
• Perform analysis on quality and manufacturing indicating data and recommend actions for compliance and process improvements.
• Consolidate quality metrics and reporting in collaboration with respective QA reporting heads.
• Perform review of root-cause analysis and other problem solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
• Participate in regulatory / FDA inspections and audits by providing information and/or acting as scribe. Expediting / obtaining information required by the inspectors / auditors.
• Prepares and presents progress reports for senior management.
• Identify and resolve emerging issues that may impact project or corporate goals.
• Recognize potential threats to project success and elevate issues to senior management.
• Develop and implement contingency plans.
• All employees are responsible for ensuring the compliance to company documents, programs, and activities related to the health, safety, environment, energy, and quality management systems, as per their roles and responsibilities.

Technical Skills (Strongly Preferred)

• Technical experience in microbiology and aseptic processing in a pharmaceutical manufacturing environment
• Experienced in creating and managing Contamination Control Strategies.
• Experienced in authoring and reviewing SOPs, work instructions, and risk assessments (e.g. FMEA)
• Familiar with Aseptic Process Simulations (Media Fills)
• Familiar with aseptic drug product manufacturing including isolator technology
• Capable of leading cross-functional meetings and providing technical leadership from a microbiology / sterility assurance perspective

Requirements:

• Bachelor degree in science with a minimum of 3+ years of progressive challenging QA/QC experience in a pharmaceutical or related regulatory industry.
• Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements.

The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.