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\xe2\x80\x99s 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 The Operation Compliance Specialist is responsible for working with all documentation changes in the manufacturing area, this including and not limited Batch Record, SOP, Job Aids, Line Clearance templates revisions, SOJT and updates as required by CAPA\xe2\x80\x99s, process improvements, Audit Observations, and any other project from supporting areas that require documentation revision.
They will support event discussions and tracking of system CAPA closures as per assessment completion within due dates. Gathering information needed to assist in closing event records.
How You Will Achieve It
Responsible for the revision of departmental SOP\xe2\x80\x99s including all supporting documents, Batch Records, training of updated documentation, SOJT, and CAPA investigations revisions closures.
Required to work with the following site systems such as PDOCS, Open Content, QTS including Change Control systems, QMS and SAP.
Classifications of Level of Training per Changes implemented.
Responsible for Training in all implementations and changes done to documentation in the Manufacturing area.
Responsible in gathering information for closure of event records open.
Attend meeting regarding open events as needed and documentation revisions.
Responsible to participate in Audits and complete responses per area assigned per operations areas.
Qualifications
Must-Have
Requires 3 years in the role of Line Coordinator, Group Coordinator or Process Technician in the applied for production area.
Must have manufacturing type background with general knowledge of regulatory and cGMP requirements.
HS Diploma required.
Computer knowledge in Microsoft word, Excel, and Power point.
Excellent writing skills required.
Nice-to-Have
Experience in a start-up environment.
Physical/Mental Requirements Use computer terminal 6 hours per shift, respond to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear PPE (safety shoes/glasses/etc), Stand up to 4 to 5 hours per shift, sit for up to 5-6 hours per shift.
Non-Standard Work Schedule, Travel, or Environment Requirements Must be flexible to stay over shift or come in early and cover alternating shift as business needs determine it.
Work Location Assignment: On Premise.
Other job details
Last day to apply: April 4, 2023.
Eligible for employee referral bonus: Yes.
#LI-PFE
Relocation assistance may be available based on business needs and/or eligibility.
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\xe2\x80\x99s 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. Manufacturing #LI-PFE
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