The production supervisor position is responsible forimplementing and supervising all activities in the production area to ensuremanufacturing goals and project deadlines are met while maintaining compliancewith current good manufacturing practices (cGMPs), environmental health andsafety (EHS) guidelines and any other regulations that could apply. Focus is on optimization for the use of rawmaterials, equipment and personnel in producing quality products. May monitor and control labor and capitalexpenditures. May assist in developingbudgets. Recommends manufacturing policies, procedures and programs.
Supervisor is expected to provide guidance, support,direction and leadership through positive interactions with all personnelduring daily operations.
Responsible for supervising the day-to-day production,scheduling, staffing, material management, compliance, training and auditingactivities - to meet customer requirements including deadlines and qualitystandards.
Interview, hire, coach, motivate, develop and disciplinestaff. Conduct annual performancereviews for all direct reports. Assist in setting performance objectives anddevelopment plans. Monitor progress.
Review, approve, and manage documentation for batch andsystem records. Assist in release ofproduct for distribution. Assist inmeeting product release time goals.
Emphasize training programs designed to enable staff toconsistently execute all manufacturing processes with strict compliance tocGMPs and EHS regulations.
Develop and implement performance measurement andinternal auditing programs in order to routinely evaluate operation efficiencyand quality. Implement changes as neededbased on assessments.
Perform/lead technical reviews, investigations andprocess improvement projects. Providemanufacturing input into integration and validation of new equipment andprocesses.
Resolves technical, material and cGMP problems that mayimpact project deadlines. Provideguidance and troubleshooting assistance as needed during a deviation in theprocess.
Represent the company during FDA inspections. Provide information as necessary to FDA thatestablishes credibility and demonstrates compliance with cGMPs.
Provide a positive and equitable working environmentemphasizing the Shire Shared Values: Respect /Responsiveness / Results.
Demonstrated interpersonal and leadership skills withability to interface well with other departments, and lead effectively andefficiently in a team environment.
In-depth processknowledge of related manufacturing equipment and processes.
Ability to managemultiple priorities in a manufacturing plant setting.
Ability toanalyze and interpret scientific, and statistical data.
Strongprofessional writing skills and ability to prepare technical reports.
Experiencedunderstanding of cGMPs and other regulatory guidelines applicable to themedical/pharmaceutical industry.
Strong assessmentand troubleshooting skills.
Ability to respondto detailed inquiries, and present information to groups and senior management.
May be required tosupervise multiple groups/shifts.
Overtime may berequired at times.
Good computer skills.
BS degree in a scientific or engineering discipline with3-5 years of manufacturing experience or AA degree or equivalent manufacturingexperience. Plus 4-6 years supervisoryrelated experience required.
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.
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Pay Transparency Policy
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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.