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Pfizer: One of the World's Premier Biopharmaceutical Companies

Associate QA, Microbial Control (4843673_Sanford)

Pharmaceuticals

All

Yearly

Full Time

No

Sanford, North Carolina, United States

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality activities associated with Microbial Control of the Sanford facility. Key responsibilities are supporting investigations, reporting on microflora present in the facility, and researching and implementing new environmental monitoring technologies.

At a minimum, the individual should be able to demonstrate the following:

  • Demonstrate increasing depth of knowledge within own work area and begin to understand other cross functional areas.

  • Able to develop and execute protocols for the Microbial Control Strategy, including investigational testing, rapid environmental monitoring technologies etc.

  • Utilize method 1, yellow belt tools to address simple problems and continuous improvement ideas under limited guidance/coaching. Knowledge of basic QRM principles.

  • Act as an individual contributor and be open and accepting of own personal areas for development.

  • Makes decisions that require knowledge of quality systems.

  • Develop problem solving skills for technical issues.

  • Recognize when issues require more information and escalates issues appropriately and in a timely manner.

  • Recognizes the impact of procedural changes that may impact future quality tasks and decisions.

  • Able to understand one’s quality influence on a specific task.

  • Applies discipline’s principles and appropriate procedures to design and execute work against work group goals.

  • Able to review working instructions for technical content within own subject area and reference to applicable cGXPs and regulatory expectations, make value-added comments. Influence and negotiate with business line regarding content with limited guidance/coaching.

  • Established interpersonal skills (building confidence in presentations and be able to respond to questions) needed to operate in a team environment within work area.

  • Manage workload to meet established timelines.

  • Increased ability to communication effectively using various tools and techniques. Using visual aids as needed (e.g. SOP).Able to effectively communicate and establish relationships within Quality lines.

Individual should have knowledge of current US, EU, and ROW cGXP; Quality systems; Aseptic Practices; Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; and Quality Risk Management.

Preferred experience with; Laboratory Information Management System (LIMS)

ROLE RESPONSIBILITIES

Responsible for knowing, understanding and acting in accordance with Pfizer’s Values.

  • Responsible for knowing, understanding and acting in accordance with cGXP Pfizer’s values

  • Provides report outs to manufacturing regarding applicable Environmental and Utilities data, as appropriate

  • Provides environmental and utility investigational support

  • Write and execute protocols applicable to microbial control strategy

  • Evaluate Aseptic observation data to identify continuous improvement opportunities

  • Author new or revise current Standard Operating procedures related to environmental monitoring and Aseptic Practices Program.

  • Responsible for appropriate creation, review and approval of GMP documentation (sample plans, work lists, and as assigned, validation protocols, equipment records, etc.) and ensuring adherence to Pfizer standards, guidelines and values.

  • Responsible for reporting issues to management and participating in issue resolution (such as reporting variances and participating in associated manufacturing investigations, reporting hardware and software issues and assisting with troubleshooting, etc.)

  • Assessing existing environments, processes and procedures and suggesting improvements to increase compliance and innovation.

May initiate and develop project plans to ensure timely completion.

May serve on cross functional teams to facilitate communications between Microbial Control and other departments.

Qualifications

BASIC QUALIFICATIONS

  • 0-3 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

  • A BS/BA Degree in Science/related field with experience in biotech or pharmaceutical industry is preferred; however, other appropriate combinations of education and/or experience in the biotech or pharmaceutical industry are suitable.

PREFERRED QUALIFICATIONS

  • Preferred qualifications include experience with and an understanding of microbiological and environmental control principles and practices

  • Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management



PHYSICAL/MENTAL REQUIREMENTS

Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets

Intellectual capability to perform complex mathematical problems and perform complex data analysis.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities. Weekend work may be required.

Limited travel for the position; no more than 10% traveling.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control

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