QA Specialist – Langhorne, PA
Provide quality oversight as instructed in the area of complaints, recalls, change control, training, cGMP documentation review and release as it pertains to batch release, Annual Product Reviews (APR) and others as assigned.
- Provide Quality Assurance support and guidance for customer complaints received by managing the Vitus customer complaint program.
- Assign complaint numbers, review customer complaints, CMO investigations for proper root cause analysis and corrective actions. Including tracking for on-time completion of reports and associated CAPAs.
- Log/track/follow-up, email complaints and recall notifications to customers, including receiving phone calls that follow the notifications.
- Responsible for direct contact with complainants and support of positive customer relations with respect to customer complaints and inquires. Contributes to design and implementation efforts to maximize complaint efficiency and effectiveness.
- Responsible for direct contact with Contract Manufacturing Organizations to relay complaint/recall information. Track and trend complaint issues and create reports for distribution.
- Work with the Pharmacovigilance (PhV) personnel when necessary.
- Writing of investigation and discrepancy reports utilizing best practices for investigation structure, root cause analysis, and proper corrective actions. Including tracking for on-time completion of reports and associated CAPAs.
- Technical review and approval of GMP documentation in support of Validation, Product Development activities, and Change Control.
- Manage and approve Change Control Process for GMP documentation, including standard operating procedures, batch records, labeling, etc.
- Support the Management Review Process by compiling, tracking, and trending of information related to quality systems.
- Prepare Annual Product Reviews (APR). Work concurrently with multiple CMOs in compiling all information required for the proper assembly of all information needed to meet worldwide APR requirements.
- Provide QA guidance and support for all internal Virtus GMP processes to ensure compliance and decrease the likelihood of action resulting from regulatory inspections.
ESSENTIAL JOB REQUIREMENTS AND QUALIFICATIONS:
- Possess strong organizational skills for prioritizing workload and responsibilities.
- Strong written communication, interpersonal, negotiation and problem-solving skills.
- Ability to manage indirect relationships and projects successfully.
- Comprehend scientific/technical descriptions of analytical specifications and methods, manufacturing controls and processes.
- Recognize and resolve discrepancies and deficiencies.
- Proficiency with computer and familiarity with electronic document management.
- Proficiency with PC based work processors, databases and spreadsheets.
- Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
EDUCATION AND EXPERIENCE:
- Bachelor’s Degree in applicable Science.
- Preferred or equivalent experience in cGMP Pharmaceuticals and/or Sterile manufacturing and packaging following FDA and EMEA Regulations and Guidances.
- Minimum of 7 years progressive challenging QA/QC experience in the pharmaceuticals or related industry.
- In-depth knowledge of current GMP and GLP as well as FDA trends and guidelines.
- Prior technical report writing experience and exposure to change control, investigations, product quality complaints preferred.