Author Assistant Jobs in Michigan (NOW HIRING)

What You Will Achieve
The recipe author will become proficient with the standard functionality of MES (Manufacturing Execution System) PharmaSuite and work with production units to convert paper records to EBR (Electronic Batch Record). They will focus on directly authoring and configuring master batch record and templates, revisions, validation and change controls of EBR Recipes at the Kalamazoo Manufacturing Site. The recipe author will have knowledge of SAP Functions including BOM, PV and IDOC management to assist in troubleshooting issues. The recipe author will define and analyze business requirements through meeting with production units and develop detailed designs to meet those requirements. They will direct the coordination of standard work practices assuring alignment of supporting systems and reports. They will provide training to production units, troubleshooting, as well as ongoing data management for production units. In this role it is critical to be on-site engaging with operations on a regular basis to ensure understanding of processes and gathering critical parameters as well as supporting hypercare for go-live activities. The recipe author will need to have a proactive approach in managing their time and engaging the production units.
How You Will Achieve It

• Responsibilities can include but not limited to:
  Manage Electronic Batch Record (EBR) design and configuration changes, change control, updates, process reviews and alignment with associated documentation used to the lifecycle procedure.
• Facilitate, lead and participate in process mapping of business processes.
• Engagement of SME's, Leads and Operators to ensure critical parameters are being captured.
• Support end users on EBR execution and usage through training super users (as applicable).
  Be the first point of contact for electronic batch record manufacturing issues as part of sustainment team and escalate to leadership as needed.
• Background in automation integration requirements and systems to be able to support Edge Gateway, OPC Tunnelor and other automation capabilities integrated with MES.
• Having thorough knowledge of MES, recipe design, baseline configuration, writing and executing functional verification reports.
  Handling of Shop floor troubleshooting in SAP - AMPS interface for Electronic Batch Records.
• Management of IDOCs
• BT ticket follow ups and ensuring its resolution with EBR Issues.
• Ensure all the performed activities comply with respective area procedures.
• Identify deviations/exceptions and escalate to leadership by appropriate procedures.
• Adherence to safety procedure, GMP and GDP practices.
• Reassess and participate in an agile change environment to enhance the process at intervals to eliminate non-value-added activities and drive continuous improvement including supporting projects and deployments.

• Participate in cross functional teams to support, enhance, and upgrade AMPS.
• Technical document writing for procedures, jobaids and functional verification protocols creation and execution.
• Assist in the work required to train, execute, track and reporting duties for other colleagues of the EBR team.

Quality Management and Compliance:

• Ensure compliance of operations to cGMP, safety and Pfizer integrity principles at all stages of activity
• To participate in internal & external (regulatory & non-Regulatory) audits.
• Assist Manager in tracking EBR procedure updates, periodic review of EBR procedures and emergency changes as required.

Training:

• To attend the training of all applicable procedures as per schedule.
• Colleague will be responsible for cross training to be able to support all AMPS areas being deployed or sustained.
• To develop and update content for AMPS EBR training for new hires to the EBR recipe authoring team.

Here Is What You Need (Basic Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
  OR an associate's degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience.
• Computer Skills: SharePoint, Proficiency in Microsoft office suite products (Word, Excel, Power point)
• Language Skills: Effective oral and written communications skills

Bonus Points If You Have (Preferred requirements)

• Pharmaceutical experience
• Certifications: M1, Yellow Belt and/or Pfizer Human Performance methodology.
• Computer Skills: EBR Recipe Design and Authoring, PharmaSuite, AMPS (MES), HTML, Java, or object oriented programming.
• Focused in Systems Analyst/Data Management.
• Experience working in Quality Tracking Systems.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform mathematical calculations and ability to perform complex data analysis
  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  Occasional travel may be required (<5%)
• In this role it is required to be onsite 5 days a week

Work Location Assignment: On Premise
The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. 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 does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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 endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
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