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Compliance Remediation Specialist Job Details

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Job Ref:  8699BR
Job Type:  Full Time
State:  North Carolina (NC)
City:  Rocky Mount
Post Code:  Jan 20, 2012
Job Description:  Aspire...to save others' lives, while shaping your own

Job Overview:
Responsible for reviewing pharmaceutical product technical data and related documentation for remediation programs. Organizes and summarizes technical information (e.g. batch records, specifications, procedures, reports, SOPs, etc.) and provides recommended corrective actions. Performs impact assessments. Initiates, directs and/or conducts investigations and corrections.

MAJOR DUTIES AND RESPONSIBILITIES:
- Identify and source product and process specific information and data from Hospira sites, personnel, and databases as directed by Program Manager

- Gather, compile, analyze and summarize data.

- Investigate to the depth commensurate with the identified risk.

- Prepare summaries, conclusion and remediation steps connected to specific project timelines

- Identify commonalities and linkages in different product reviews and optimize common remediation activities.

- Active member of the remediation team to rectify the gaps identified in the gap assessments working within a cross functional team which may include R&D, Quality, Manufacturing, Engineering, Regulatory Affairs, and Documentation Control.

- Travel to other Hospira sites as needed.Position is located in Rocky Mount, NC

Requirements

Skills/Experience/Education
- Candidate must have a Bachelor's degree, preferably with an educational background in science or engineering in order to interact effectively with project technical resources experienced in Pharmaceutical R&D, Engineering, Quality Assurance and Regulatory Affairs.

- Excellent verbal and written communication skills and attention to detail

- Proficient with Microsoft Office.

- Capable of organizing data from multiple sources, extracting key information and writing reports and summaries
- Demonstrated ability to write logically and consistently

- Strong critical thinking and problem solving skills

- Resourceful and innovative approach

- Ability to work cross-functionally with a diverse team

Why It's a Great Place
Employees are offered an agile yet balanced work atmosphere, incentive compensation and the benefits that you'd expect from an industry leader.

- Annual bonus potential- Consumer-directed medical plan options

- Health Reimbursement Account (HRA) and Health Savings Account (HSA) options that allow you the maximum flexibility in managing your health and health care spending - Extensive preventive care benefits covered at 100%

- Dental /Vision plan- Flexible spending accounts

- health care and dependent care

- Paid vacation and holidays

- Life insurance, short/long-term disability, AD&D

- Optional long-term care insurance

- Adoption assistance/Employee Assistance Program and work/life benefits

- Generously matched 401(k) retirement savings plan including immediate vesting, numerous investment alternatives and loan provisions

EOE

01/21/2012
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