Quality Inspector- 3rd Shift 10p-6:30a

ROLE SUMMARY

The Quality Inspector will be able to audit GMP documents for aseptic pharmaceutical processes for conformance to established specifications, procedures, cGMPs, and FDA regulations and identify non-conformances. The position requires excellent written and oral communication skills and the ability to work effectively across multiple departments to achieve initiatives. Quality Inspectors must be able to work well with personnel at all levels throughout the organization including peers, operations personnel, supervisors and managers. This role requires the ability to perform job related tasks at a high level independent of direct supervision.

This position is for third shift, standard hours: 10pm - 6:30am

ROLE RESPONSIBILITIES

The essential functions of the position may include, but are not limited to:

• Communicate non-conformances found during aseptic processing operations to the QA Supervisor/Manager on shift
• Follow established procedures and identify gaps as written
• Attend/participate in monthly In Process Batch Record Review
• Floor QA point of contact to MQA and Production Management
• In-process review of production batch records for accuracy of documented entries and conformance to established procedures 
• Perform inspection readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities
• Must be able to complete aseptic gowning qualification and work daily in a Grade A/B classified area
• Understand and demonstrate aseptic techniques and behavior required in aseptic processing areas
• Observe for aseptic techniques during processing and ensure process interventions are performed per procedures
• Perform quarantine and rejection of basic units, components, material, etc. Perform PRISM transactions, as applicable
• Must be willing to work overtime to support business initiative
• Weekend hours (Saturday and/or Sunday) may be required

BASIC QUALIFICATIONS

• High School degree required; Bachelor’s degree in a scientific discipline is preferred.
• Minimum of 1-3 years of related experience and/or successful completion of a job-specific training program or equivalent combination of education and experience is recommended.
• The ideal candidate will possess a combination of relevant education and work experience, and/or successful completion of a job-specific training program.
• Non-Standard Work Schedule, Travel or Environment Requirements.
• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.

  

PHYSICAL/MENTAL REQUIREMENTS

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. While performing the duties of this job, the employee must don a full body garb suit, hood, mask, goggles, and gloves. The employee will also be required to remain in the full body garb suit, hood, mask, goggles, and gloves for several hours at time.

Must have schedule flexibility, depending on the production schedule employees may be required to periodically work overtime, off-shifts (mornings, afternoons, nights or a combination of both), weekends and/or holidays. Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

Must have the ability to work effectively under pressure and conform to strict production, time and performance deadlines.

This is a full-time, third shift, position in the production floor / Aseptic area.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays, and hours outside defined shift hours.
• Must be able to gown aseptically.

The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.

Last date to apply for job: August 10, 2021

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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