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Posted : Wednesday, April 17, 2024 02:43 PM
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 This position is responsible for technical writing and administration of the Microbiological Contamination Control Strategy documents and related process documentation.
Responsibilities include partnering with cross-functional teams in the development of new documents, review of cross-functional procedures, maintenance of MCCS documentation and ensure that the information and documentation conforms to Pfizer policy and cGMP’s and all other applicable regulatory guidelines.
Additionally, responsibilities include facilitating Quality Risk Management (QRM) development and revision.
You are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment.
You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements.
Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables.
You will arrive at decisions on which methods and procedures are the best fit for different work situations.
You will train others and reinforce behaviors that will help us achieve our goal of providing the best to patients.
How You Will Achieve It Annual review, change control and storage of GMP numerous MCCS documents all within appropriate systems Lead cross-functional teams to develop new MCCS and related documentation Lead cross-functional teams to ensure historical QRMs are up to date and support development of new QRMs Proactively review cross-functional procedures and processes and enter various GMP facilities to ensure MCCS documentation conforms.
Independently work in multiple GMP and Engineering systems to determine endpoints of production processes Support regulatory audits as needed Qualifications Must-Have High School Diploma or GED 6+ years’ experience Technical writing capabilities are required.
Certification in assigned area, if applicable Successful hands-on analytical testing experience in a Good Manufacturing Practices {also cGMP} environment Demonstrated proficiency in applicable computer software and systems Demonstrated attention to detail, personal leadership and accountability in day-to-day interactions with an operational regard for customer needs and process requirements Must have strong organizational skills and an ability to multi-task across projects and activities Good communication skills for written reports Basic computer skills in Microsoft Office Nice-to-Have Bachelor's Degree Applicable experience in quality functions of pharmaceuticals industry Proficiency in using GMP and engineering systems PHYSICAL/MENTAL REQUIREMENTS Office position with time in the production environment.
Position will require extended periods of sitting.
Occasional lifting of up to 25 lbs is possible.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Overtime or weekend work may be necessary.
Work Location Assignment: On Premise Last Day to Apply: December 27th, 2023.
The salary for this position ranges from $25.
59 to $42.
65 per hour.
In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
Learn more at Pfizer Candidate Site – U.
S.
Benefits | (uscandidates.
mypfizerbenefits.
com).
Pfizer compensation structures and benefit packages are aligned based on the location of hire.
The United States salary range provided applies only to the United States - Michigan - Kalamazoo location.
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.
Quality Assurance and Control
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 This position is responsible for technical writing and administration of the Microbiological Contamination Control Strategy documents and related process documentation.
Responsibilities include partnering with cross-functional teams in the development of new documents, review of cross-functional procedures, maintenance of MCCS documentation and ensure that the information and documentation conforms to Pfizer policy and cGMP’s and all other applicable regulatory guidelines.
Additionally, responsibilities include facilitating Quality Risk Management (QRM) development and revision.
You are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment.
You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements.
Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables.
You will arrive at decisions on which methods and procedures are the best fit for different work situations.
You will train others and reinforce behaviors that will help us achieve our goal of providing the best to patients.
How You Will Achieve It Annual review, change control and storage of GMP numerous MCCS documents all within appropriate systems Lead cross-functional teams to develop new MCCS and related documentation Lead cross-functional teams to ensure historical QRMs are up to date and support development of new QRMs Proactively review cross-functional procedures and processes and enter various GMP facilities to ensure MCCS documentation conforms.
Independently work in multiple GMP and Engineering systems to determine endpoints of production processes Support regulatory audits as needed Qualifications Must-Have High School Diploma or GED 6+ years’ experience Technical writing capabilities are required.
Certification in assigned area, if applicable Successful hands-on analytical testing experience in a Good Manufacturing Practices {also cGMP} environment Demonstrated proficiency in applicable computer software and systems Demonstrated attention to detail, personal leadership and accountability in day-to-day interactions with an operational regard for customer needs and process requirements Must have strong organizational skills and an ability to multi-task across projects and activities Good communication skills for written reports Basic computer skills in Microsoft Office Nice-to-Have Bachelor's Degree Applicable experience in quality functions of pharmaceuticals industry Proficiency in using GMP and engineering systems PHYSICAL/MENTAL REQUIREMENTS Office position with time in the production environment.
Position will require extended periods of sitting.
Occasional lifting of up to 25 lbs is possible.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Overtime or weekend work may be necessary.
Work Location Assignment: On Premise Last Day to Apply: December 27th, 2023.
The salary for this position ranges from $25.
59 to $42.
65 per hour.
In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
Learn more at Pfizer Candidate Site – U.
S.
Benefits | (uscandidates.
mypfizerbenefits.
com).
Pfizer compensation structures and benefit packages are aligned based on the location of hire.
The United States salary range provided applies only to the United States - Michigan - Kalamazoo location.
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.
Quality Assurance and Control
• Phone : NA
• Location : Kalamazoo, MI
• Post ID: 9026025298
