Aseptic Compliance Process Specialist
Job Description
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
Provides direction for aseptic requirements, aseptic processing principles, with support for production areas, methods and sterilization processes that supports development for manufacturing operations. Technical experience in a variety of Aseptic Processing Principles (clean room environment), Aseptic Sampling, Disinfection, and sterilization topics. Serves as a contributor to process deviation reporting, investigation and determination of root causes. Leads efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
Display technical experience in aseptic techniques, principles, theories, concepts and industry practices/standards. Writes evaluations to support Change Control Requests, ROIs, URS, etc. Also writes SOP’s, technical reports, project plans, etc. Focuses on leading/participating in defined projects. Some hands-on work in the Aseptic Processing Area will be required.
How You Will Achieve It
Provides operational support to the aseptic training organization which includes but is not limited to oversight of aseptic observations, SOP’s, and training curricula.
Train new colleagues in proper aseptic gowning techniques.
Observe and coach colleagues in aseptic practices.
Investigate deviations associated with Environmental Monitoring, Personnel Monitoring, Aseptic Facility, and other associated aseptic deviations. Performs root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, ie engineering, maintenance, quality, validation, environmental health and safety.
Identifies and helps implements cost savings ideas, specifically area efficiency improvements.
Sustain standard work practices with the aseptic facility.
Support cost saving initiatives, regulatory changes, and network requests associated with aseptic practices/facilities as needed.
QUALIFICATION
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+years of experience.
Communication:
Strong written and verbal communication skills
Tactful, persuasive and assertive human relations skills
Effective leadership skills
Comprehensive knowledge of cGMPs, applicable SOPs and production processes, and inspection practices
Ability to multi-task and manage projects to an established timeline.
Nice-to-Have
Experience leading colleagues that perform aseptic activities.
Proficient using Quality Tracking System (QTS).
Knowledge of manufacturing and regulatory compliance.
Knowledge of computer systems and Microsoft Office Suite.
Able to work individually and in a matrix team structure.
PHYSICAL/MENTAL REQUIREMENTS
- The capability to aseptically gown. Vision must be correctable 20/20.
- Must not have a Penicillin allergy.
- Achieve acceptable personnel monitoring results.
- Long periods of standing may be involved.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Schedule is on 1st shift, standard Monday - Friday. Some weeknight and weekend work may be required.
Work Location Assignment: On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: September 9, 2024
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
