The Production Lead is responsible for providing detailed technical training to work team colleagues. Liaison between work team and maintenance for repairs and preventative maintenance. Generates work orders and insures work is completed correctly in a timely manner. Also responsible for supporting the work team operation to ensure that applicable safety guidelines/policies are followed, and that all tasks are conducted in accordance with appropriate processing standards, such as FDA's current Good Manufacturing Practices (cGMPs).
ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.
ROLE RESPONSIBILITIES
Assists in the development of operator care task sheets. Develop training components, provide training, and help track training and status through PLS for colleagues. Establish efficient processes, monitoring specific results, and improve identified process opportunities. Assist in identifying problems and solutions using M1. Serve as technical subject matter expert for the work team and provide support for equipment related deviations. Work with engineering by participating in developing equipment specifications, user requirements, capital scope development, FAT/SAT support and qualification activities. Work with procurement and packaging engineering to monitor component issues and conduct feasibility assessments/line trials as needed. Assist in the development of IQ/OQ/PQ documents. Review and approve GCR documents.
Production Lead will work with the aseptic area training and quality to develop, implement, and execute aseptic technique and behavior training, assessments, and auditing.
As directed by supervision, the Production Lead may be responsible for day to day floor operations, daily line assignments, serving as person in charge in the absence of a supervisor, attending scheduling meetings, filling out the daily shift report, writing QAR’s, writing PTVA’s, OEE, and reviewing and requesting SOP and document revisions.
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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.
Sunshine Act
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.
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