About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Second level position with previous training and knowledge in cGMP's relevant to the pharmaceutical industry and aseptic processing. The incumbent will be able to audit aseptic processes for conformance to established specifications, procedures, cGMPs, and FDA regulations and identify any non-conformances. The position requires excellent written and oral communication and the ability to work effectively across multiple departments to achieve initiatives. The incumbent must be able to work well with personnel at all levels throughout the organization including peers, operations personnel, supervisors and managers. This role requires the ability to perform job related tasks at a high level independent of direct supervision.
The essential functions of the position may include, but are not limited to:
• Communicate non-conformances found during aseptic processing operations to the QA Manager / Supervisor on shift.
• Interpret and follow established procedures as written.
• In-process review of production batch records for accuracy of documented entries and conformance to established procedures
• Perform inspection readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities.
• Must be able to complete aseptic gowning qualification and work daily in a Grade B classified area
• Understand and demonstrate aseptic techniques and behavior required in aseptic processing areas
• Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues.
• Must be willing to work overtime to support business initiatives.
• Weekend hours are required.
HS/GED with one year general work experience and one to three months related experience
and/or successful completion of a job-specific training program or equivalent combination of
education and experience.
Knowledge Necessary to Perform the Job:
• Knowledge of 21 CFR 210 and 211 cGMPs and part 11 to determine materials disposition.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. While performing the duties of this job, the employee must don a full body garb suit, hood, mask, goggles, and gloves. The employee will also be required to remain in the full body garb suit, hood, mask, goggles, and gloves for several hours at time. Must have schedule flexibility, depending on the production schedule employees may be required to periodically work overtime, off-shifts (mornings, afternoons, nights or a combination of both), weekends and/or holidays.
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.
This is a full time position in the production floor / Aseptic area.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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. 2nd and/or 3rd shift, Saturday through Wednesday.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company 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. the company 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.
A little about us:
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