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
What You Will Achieve
You will help us in investigation of our quality issues in
manufacturing and quality laboratories. You will investigate
deviations, equipment failures, calibration out-of-tolerance
results, validation out-of-specification results, and atypical
result investigations. Your problem solving skills will help to
identify root cause and suggest appropriate corrective action plan.
Your attention to detail will help us ensure that the reports are
aligned to regulatory requirements and company policies.
As a Senior Associate, your knowledge and skills will contribute
towards the goals and objectives of the team. Your focus and
ability to meet team targets will help in completing critical
deliverables. Your innovative use of communication tools and
techniques will facilitate in explaining difficult issues and
establishing consensus between teams.
It is your hard work and commitment that will help in making
Pfizer ready to achieve new milestones and help patients across the
How You Will Achieve It
* Contribute to the completion of complex projects and manage
own time to meet agreed targets.
* Develop plans for work activities on own projects within a
* Perform, lead and review deviation investigation reports,
change control and validation/qualification.
* Provide direct input or coaching support for other functional
groups in investigations.
* Manage investigations and apply relevant and necessary
actions/ systems to ensure appropriate levels of compliance.
* Support regulatory audits through the preparation, defense and
interaction with auditors for requested investigations.
* Provide expertise for trouble-shooting and resolution of
issues related to business processes, equipment, facilities,
utilities and human performance.
* Assess potential impact of changes to qualified systems
resulting from investigational CAPAs.
* Identify and implement investigational best practices to
continuously improve the site performance.
* Represent Engineering and Maintenance on site or network teams
* The position requires execution and management of multiple
initiatives at the same time and good communication skills to keep
customers, peers, and area management up-to-date with progress of
all such efforts.
* Bachelor's Degree (Science or Engineering preferred)
* 3+ years' experience in pharmaceutical industry
(manufacturing, laboratory, engineering or biotechnology)
* Proven record of problem solving, decision-making skills and
application of process improvement tools
* Strong background and knowledge in manufacturing, compliance
and technology investigations, processes and systems
* Must be comfortable working both independently and
* Effective communication skills are required, both written and
* Computer literate, with superior skills in managing Excel
* Master's degree
* Experience with investigations, including conducting and
writing investigations, using methodology
* Direct knowledge and experience in 6 Sigma and Lean
methodologies and relevant experience in a biopharmaceutical or
pharmaceutical cGMP environment is required.
* Experience with FDA and EU licensing and inspection is
* Experience with project management is desired.
Position requirements are typical for an office-based work
environment with some shop floor exposure. There are no unusual
physical or mental requirements for this position.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT
Schedule is primarily day shift (M-F, 8 hrs) but may require
off-shift work on occasions. The position may require working on
the floor in manufacturing or utility areas at times which will
require a focus on safety. Aseptic gowning could be required.
* Last day to apply 4/29
* Employee Referral Bonus eligible
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