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Job Title:
QA Specialist II - Compliance
Department/Group:
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Location:
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Reports to:
QADir., Quality Systems & Compliance
FLSA Status:
Exempt
Prepared By:
Michelle Herrick
Date:
9/12/2023
Approved By:
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Date:
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Summary of Objective:
This position is responsible for maintaining and adhering to PCI Pharma Services and regulatory compliance requirements for established quality system programs by performing internal audits, hosting client audits and providing assistance during regulatory agency inspections.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Responsible for scheduling and hosting client audits and coordinating audit responses for any deficiencies from internal stakeholders. Responsible for follow up and tracking of client audit observation commitments to assure timely closure. Responsible for performing internal and audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports and coordinating audit responses for any deficiencies from internal stakeholders. Responsible for follow up and tracking of internal audit observations commitments to assure timely closure Responsible for reviewing and approving all audit responses to assure non-recurrence of deficiencies Maintain, trend, analyze and report quality metrics as it relates to internal and client audits Provide support and metrics for Quality Council meetings Provides support during FDA and other regulatory agency inspections Writes and revises QA Standard Operating Procedures (SOP) Support continuous improvement initiatives May be assigned to assist with supplier audits as needed. Less than 10% travel. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
On an average day, the individual can expect to move and/or transport up to 10 pounds
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This position may have the following special vision requirements.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
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Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
Preferred:
Ability to communicate clearly and concisely with cross functional staff, members of management and external clients.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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