Job Description

Job Description

Job Description

Description:

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.

Summary:

The Global Complaint Investigator is responsible for administration of the corporate complaint system at SCA. This person interfaces with management and system owners at all SCA facilities in collecting information, conducting investigations, preparing documentation, communicating, and processing of customer complaints. In particular, the Global Complaint Investigator interfaces with third parties who SCA retains to process adverse events and regular complaints. This position requires advanced understanding of site processes and standard operating procedures to conduct suitable investigations in determination of root cause.

Essential Functions:

• Initiate customer complaints and complaint investigations.
• Process documentation associated with customer complaints, adverse events, recalls, market withdrawals, and similar quality systems in accordance with SOPs and cGMP compliance.
• Conduct concise investigations associated with customer complaints and adverse events.
• Coordinate with system owners in determination of root cause, identification of suitable corrective actions, and ensure that the corrective actions are complete per SOPs.
• Perform inspections of complaint investigation customer returns and in-house reserves as part of investigations.
• Document investigation results using standard business English and writing skills.
• Report compliant investigation outcomes to customers.
• Generate suitable metrics, reports, and data that illustrate the complaint and adverse event processes, recalls and market withdrawals, as necessary.
• Review data for trends and ensure high risk / systemic issues are identified and escalated promptly.
• Communicate those metrics to appropriate management and system owners.
• Monitor compliant investigation CAPA’s, ensure effectiveness and adherence to timelines / customer commitments.
• Lead cross functional meetings related to complaints
• Author Quality documents for the site including standard operating procedures (SOP’s).

Required Qualifications & Experience:

• Bachelors degree in a Regulatory, Biotech, Pharmacy, or related Scientific field
• 2+ years’ experience in a GMP Quality role.

Desired Knowledge, Skills and Abilities:

• Proven ability to quickly and accurately draft written information.
• Demonstrated ability to interact and converse with third parties, representing SCA in a positive manner.
• Strong attention to detail
• Goal oriented, with excellent time management and organizational skills
• Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
• Excellent verbal & written communication skills
• High level of proficiency with PC based software programs

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.

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