16 days old
2017-11-292017-12-29

MQA Specialist I (split shift, M

Pfizer
Brentwood, MO
**Role Description**



This posting is for a split shift position on the Brentwood QA team supporting Injectable products. The Brentwood QA team is a focused team whose responsibility is to ensure timely review of batch records, release of raw materials, and timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA) while ensuring that manufacturing operations conform to established standards and specifications.







**Responsibilities**



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



1. Proficiency in the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations.



2. Reviews Batch Records for compliance to SOPs and determination of batch acceptability.



3. Becomes Aseptic Processing Area (APA) Gown Qualified for the following Tasks:







+ Performs Line Clearances / Verifications in the APA. Utilizes critical Aseptic thinking skills to work through challenging situations.



+ Performs on-line auditing in the APA.







4. Assists and supports the manufacturing staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.



5. Participates in understanding failures and resulting CAPAs through notice of event reports.



6. Maintains proficiency in performance of all applicable Manufacturing/Quality, etc. SOPs for this area.



7. Assists in review and editing of SOPs / Master Batch Records.



8. Participates in internal GMP audits and supports customer and regulatory audits.







**Qualifications**



Education: BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering or other science related discipline.



Experience: 1-2 years of pharmaceutical experience and/or training; or equivalent combination of education and experience. Experience at a manufacturing site preferred. Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.



Analytical - Collects and researches data; analyzes information skillfully.



Technical Skills - Excellent knowledge of manufacturing operations for evaluation of batch status; demonstrated knowledge of laboratory testing and data collection for raw materials and products for evaluation of batch status.



Oral Communication - Listens carefully and gets clarification. Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel.



Team Work - Contributes to building a positive team spirit.



Written Communication - Writes clear, accurate and concise technical and non-technical documents.



Diversity - Shows respect and sensitivity for personal and cultural differences.



Interpersonal - Interfaces with management and non-management employees in manufacturing, packaging, Inspection, engineering, pharmaceutical technology, regulatory affairs, quality assurance and laboratories.



Ethics - Works with integrity and ethically. Maintains confidentiality.



Organizational Support - Supports organization's goals and values. Willing to work together to achieve a common goal.



Adaptability - Able to deal with frequent change, delays, and/or unexpected events.



Dependability - Completes tasks on time or notifies appropriate person of impending delays with an alternate course of action.



Innovation - Meets challenges with resourcefulness.



Judgment - Exhibits sound and accurate judgment.



Professionalism - Treats others with respect and consideration regardless of their status or position.



Quality - Produces analytical work of high quality. Looks for, and suggests ways to improve and promote quality.



Safety and Security - Understands and follows all safety and security procedures, industrial and company based; looks for and suggests safety improvements.



PHYSICAL/MENTAL REQUIREMENTS Office position with time spent in the production environment.



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 and manage to strict production, time and performance deadlines.



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.







**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.







This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.







**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.







**Other Job Details:**







+ **Last Date to Apply for Job: December 12, 2017**



+ Additional Location Information: St. Louis, MO







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Categories

  • Engineering
  • Financial Services
  • Government
  • Legal
  • Manufacturing / Production
  • Healthcare

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MQA Specialist I (split shift, M

Pfizer
Brentwood, MO

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Pfizer
Brentwood, MO
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