Specialist, Analytical Quality Control *PC 1540

Your Role:

This position will be in the Manufacturing Science and Technology team (MS&T) at Gaithersburg, MD site. This position is responsible for life cycle management of analytical methods, worksheets and leading analytical method related quality events (change controls, deviations, CAPAs). In addition, this position will support MSAT team to manage analytical method changes, qualification of materials, supplier change notifications related to the Cell and Gene Therapy processes.

Additionally, the specialist will partner closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively.

Essential Duties and Responsibilities:

• Investigate Deviations: Analyze and investigate deviations or out-of-specification (OOS) results from analytical testing to identify their true root cause.
• Change Management: Initiate/owns change controls or respective quality event to drive changes to the method, equipment, or material.
• Documentation: Maintain accurate, detailed, and objective documentation of all investigation findings, test results, and analytical method SOPs in compliance with regulatory requirements.
• Root Cause Analysis: Utilize problem-solving tools like root cause analysis to determine the source of quality problems.
• CAPA Implementation: Collaborate with cross-functional teams to develop, implement, and track corrective and preventive actions (CAPAs) to prevent recurrence of deviations.
• Technical Support: Provide technical expertise in analytical methods, instrumentation, and quality systems to support projects and resolve quality issues.
• Method Support: Troubleshoot analytical methods and instrumentation and support method validation and implementation.
• Compliance & Audits: Ensure all activities comply with Good Manufacturing Practices (GMP), FDA guidelines, and other relevant regulations.

Requirements:

• Bachelor's degree in science/engineering or related field; At least 3 years of related experience in a GMP biologics Quality Control environment; Or a combination of education and experience.
• Prior handling of analytical methods like Flow Cytometry, dPCR, Potency is highly preferred.
• Previous GMP experience in handling quality control related deviation, change controls, CAPA using appropriate quality system is required.
• Worked in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
• Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines.
• Experience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to evaluate trends.

Skills:

• Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).
• Project management skills including planning, execution, risk and change management.
• Effective team player.
• Analytical skills with logical thinking problem solving skills.
• Good knowledge of Microsoft office.
• Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
• Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments. Prepare periodic reports and present data to internal and external stakeholders as needed.
• Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a controlled biological manufacturing cleanroom and microbiology laboratory, using such equipment as particle counters, air samplers, biosafety cabinets, incubators, plate readers and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $85,500- $93,050/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.