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QO Compliance Specialist

ROLE SUMMARY
Microbiologist:
The successful candidate will provide microbiological subject-matter expertise within the department, to support microbiological assay testing laboratories. Provide expertise and support in microbiology and Environmental monitoring for biological API product.
Performs standard microbiological and bioassay tests for conformance to company and compendia specification. Provide necessary support for performing and executing cleaning validations.
Regulatory support:
Accountable for activities involved in supporting Quality change control system
DMF and Site Master file update
APR program management
Quality oversight for the Document Retention Program
Manage the Site Readiness Program. May also support internal audit activities.
ROLE RESPONSIBILITIES
Responsible, among other things for:
+ SME for Biological product
+ Evaluation and Completion of RONA Reports
+ Preparation of Annual Product Reports (APR)
+ Manage Regulatory queries and responses
+ Manage Regulatory Change Controls for permanent changes.
+ Other activities as identified by the supervisor
+ Internal audits
BASIC QUALIFICATIONS
+ BS/BA with at least 5 years of experience in Microbiology
PREFERRED QUALIFICATIONS
+ BS/MS with at least 2 years of experience in Pharmaceutical Industry
+ Accountable for adhering to Pfizer standards, guidelines and values
+ Must be detail oriented and able to make sound decisions. Proactively identifies and resolves potential problems with basic complexity. Working knowledge of cGMP with high productivity and ability to multi-task coupled with a low error rate.
+ Good oral, and written communications skills and computer literacy
+ Manages own time and professional development; accountable for own results. Work is performed under broad guidelines and with limited supervision. Ensures completion of any team assignments
+ Identifies and implements processes to improve performance and increase efficiency, consciously balancing the risk and reward trade-off
PHYSICAL/MENTAL REQUIREMENTS
+ While performing the duties of this job, the employee is exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and /or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus
+ Position requires regular onsite attendance, this position cannot be performed on a remote / telecommute basis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
+ Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements
+ Must have the ability to work effectively under and manage to strict production, time and performance deadlines
+ 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
ORGANIZATIONAL RELATIONSHIPS
+ Routine interaction with Site' colleagues (Production, Quality Control, Technical Services, Site Services and Site Leadership Team) and Global Suppliers
+ Periodic interaction with other Pfizer colleagues ( Other Sites, GCMC, COQA, MSQA, BT)
+ Sporadic interaction with other site customer and regulatory agency representatives
RESOURCES MANAGED
+ Provide support during budget preparation process and control expenses (Avg. QO Budget: $ 3MM)
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.
Other Job Details:
+ Last Date to Apply for Job: November 7, 2018
+ Additional Location Information: Franklin, OH
+ No Relocation eligible
+ Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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