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QC Environmental Monitoring - Supervisor Wed-Sat 6:00 a-4:30p

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POST DATE 9/10/2016
END DATE 11/17/2016

Shire Pharmaceutical Lexington, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
14579BR
AJE Ref #
576133996
Location
Lexington, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Job Description
PRIMARY ROLE:
Monitors daily operations of a unit and actively assists, or provides direction to,
subordinates as required. May perform, especially in staff or professional groups,
ongoing operational tasks of organizational units.

Discretion/Latitude:
Erroneous decisions or failure to achieve results will cause delays in schedules.
Impact:

Ensures that projects are completed on schedule following established procedures and schedules. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources

Specific QC Focus Areas:
Environmental Monitoring
Area focuses on routine support for site environmental monitoring sampling procedures for facilities, critical utilities, and personnel. Also in scope is support for classification and validation initiatives that require environmental monitoring support.

RESPONSIBILITIES:
60%: Supervision of daily and weekly activities of staff and
operational oversight of group, data review, scheduling,
oversight of group training
20-30%: GMP documentation related activities (ex. SOP revisions,
quality systems related events, method related project
documents as required), oversight of group metrics
10-20%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support

EDUCATION & EXPERIENCE REQUIREMENTS:
Typically requires a bachelor s degree and a minimum of 8+ years related experience. (Science related degree is preferred)

Additional Specific Experience:
Excellent communication, interpersonal and organizational skills.
Proactive at keeping current with literature and latest technologies.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements.

OTHER JOB REQUIREMENTS:
Limited to no travel expected. Travel between sites is required.
The following physical abilities are required in order to fulfill the job duties:
-Repetitive bending and reaching to setup and break-down equipment (if required by
specific activity)
-Ability to work around chemicals (if working around the laboratories)
-Ability to wear personal protective equipment such as gloves, gowning, and respiratory
protection in some cases
-Ability to walk and stand for periods of time

ABOUT SHIRE:
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.