Quality Systems Administrator
Location: Rocky Mount
Posted on: June 8, 2019
ROLE SUMMARYThe Quality Systems Administrator performs system
analysis and identifies / implements mitigations as needed to
assure that the data generation and documentation systems are
maintained in a validated state with integral data generation for
the Rocky Mount Laboratory computerized systems. These systems
include, but are not limited to, Lab Information Management System
(LIMS), NuGenesis, Empower and other lab applications utilized for
instrument and data management to assure that data generated is
integral and complete throughout the data retention lifecycle in
conjunction with BTAMS. This position is also essential in
performing assessments of electronic and manual data generation
processes for other systems at the Rocky Mount site to assure that
data integrity is maintained throughout the data retention
lifecycle.This position performs setup / pre-launch assessments and
implements post-launch enhancements to the laboratory systems that
generate and maintain data in order to created / maintain data
integrity. Responsibilities include assessing changes to user and
testing specifications and regulatory requirements per 21 CFR Part
11, PIC/s Annex 11, GAMP5, and current regulatory Data integrity
guidance documents, determining the impact of software updates and
user requested changes with regard to product and process data
quality, and implementing appropriate measures / controls within
the laboratory systems to ensure compliance. The roles are also
responsible for performing system administration, application
support, software / hardware validation support, incident
management, technical expertise, and production support to quality
labs, lot release/supply chain, and manufacturing. Understanding of
database structure and system security is necessary for this
position.System support may include system configuration, designing
and building application reports or reporting tools, maintaining or
creating master data for new or existing products, software
utilities, maintaining system documentation, and providing ad hoc
support to other departments as needed. This position is expected
to provide leadership to support system evolution and continuous
improvement for all lab system and to support laboratory
informatics and data integrity efforts applicable to data generated
from these systems and processes.ROLE RESPONSIBILITIES
- Provides technical support for laboratory quality system to the
Quality Control laboratories, Biological Quality (BQ), Chemical
Quality (CQ), and Supplier Quality (SQ);
- Ensure that the systems comply with all applicable regulatory
standards pertaining to Electronic Records / Electronic records and
Data Integrity guidance documents.
- Diagnostic support for application associated with laboratory
data generation and management.
- Management and timely resolution of technical incidents through
the standard incident and problem management process; Responsible
for elevation of incidents to 2nd tier support and summarization
and reporting of incidents to system owners and effected users when
- Ensure site on-time implementation of laboratory quality system
through support of user requirements, functional design, and
management of master data configuration, data migration, reporting
design, system validation, SOP generation, development, and
- Provides a key role in system governance.Review and management
of system change control processes, including establishing or
revising user requirements, design requirements, functional
specification, design specifications, or qualification
- Define and manage process efficiency and continuous improvement
projects for laboratory systems for timely updates / releases.
- Technical writing for system validation protocols, standard
operating procedures, and other technical documents in support of
- Support business in data generation and evaluation processes
including, but not limited to, creation, validation, and
maintenance of reports, calculations, and queries within quality
- Support system periodic review, security review, and audit
trail review activities.
- Support audits and inspections to provide data and information
on request, provide ad hoc support to other department to assure
compliance with applicable regulatory requirements.BASIC
- Bachelor's degree in life sciences, computer science, or
engineering required. Master's degree preferred.
- Minimum of 5 years working in a GMP-regulated environment
required, pharmaceutical industry preferred.
- 2 years related laboratory application management experience
required: configuration, validation, implementation, and system
- 2 years of experience in a GMP environment with working
knowledge of laboratory specification and test documentation in
electronic systems required.
- 2 to 4 years in computer system validation and analytical
instrumentation testing required.
- 3+ years experience in LIMS system management required.
- 1+ years experience in chromatography system administration,
such as Empower required.PREFERRED QUALIFICATIONS
- Proficiency in LIMS instrument integration.
- Experience in NuGenesis, Chromeleon, or WinKQCL.
- A working knowledge of design of laboratory data
- Working knowledge or biology, chemistry, life sciences with
strong skills in computer system management.
- Knowledge of cGMPs and regulatory requirements around computer
systems including 21 CFR Part 11, GAMP5, Data Integrity Guidance
documents, and applicable ISO standards.
- Strong analytical skills and balanced decision making; must
have the ability to formulate appropriate system queries.
- Possess good communication skills and attention to detail.
- Knowledge of risk and impact assessment tools strongly
- Knowledge of root cause analysis tools and investigational
skills preferred.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT
REQUIREMENTS This role is 1st shift, Monday - Friday. May be
required to work non-standard hours to support laboratory systems
at the Rocky Mount site.EEO & Employment EligibilityPfizer 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.Sunshine ActPfizer 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: 16 JUNE 2019
- Eligible for Employee Referral BonusN (Other) (United States of
America)Pfizer is an equal opportunity employer and complies with
all applicable equal employment opportunity legislation in each
jurisdiction in which it operates.
Keywords: Pfizer, Rocky Mount , Quality Systems Administrator, Other , Rocky Mount, North Carolina
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