Objective

The Quality Assurance Specialist I will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system and corrective action and preventative actions (CAPAs). In addition, the Quality Assurance Specialist I will provide consultation in the interpretation of good manufacturing practice (GMP), good laboratory practice (GLP), and good clinical practice (GCP) regulations, guidelines, policies, and procedures. These responsibilities involve working closely with multiple departmental teams across the company.

Essential Functions

• Write, revise, review, and approve site Standard Operating Procedures.
• Review Batch Records and provide final product disposition.
• Review and assess in-house solution preparation and external material testing.
• Assist with implementation and maintenance of electronic Document Management System.
• Perform quality review regulatory submission documents.
• Review and approve documentation of GMP activities performed at contract facilities.
• Maintain QA records according to applicable regulatory requirements and Perspective policy.
• Participates in regulatory agency (i.e. FDA, etc.) inspections.
• Investigate or serve as GMP QA reviewer/approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions, as assigned.
• Ensure root causes are appropriately identified and CAPA is implemented to reduce / prevent recurrence, within required timeframes.
• Document and trend deviations / out of specifications / root causes / CAPAs.
• Participate in internal audits of GMP Quality Systems and sub systems.
• Aid in assessing risk during Vendor Qualifications or Material Assessments.
• Conducts incoming material disposition.
• Document Control, Training, Quality Systems back-up and key trainer.
• Review and compile the Annual Product Quality Review.
• Participate in inspection readiness activities and provide support during regulatory site inspections.

Qualifications

Education/Experience

• A Bachelor's Degree (or higher) in scientific discipline is strongly preferred.
• Minimum of 2 years of relevant experience in quality or regulatory compliance within pharmaceutical, biologics, or other related industries.
• Familiar with radiation safety standards and policies is preferred.
• Experience with MS Office Suite required.

Knowledge / Skill / Ability

• Excellent knowledge of GMP, GLP, and GCP requirements. 
• Knowledge of corporate governance, health care regulations, laws, and standards.
• Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.
• Understanding of Computer System Validation / Assurance requirements.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
• Ability to work in a team environment with minimum supervision required.
• Strong collaborative, partnering, and interpersonal skills.
• Excellent communication skills, both written and oral.
• High ethical standards, trustworthy, operating with absolute discretion.
• Highly organized with great attention to detail.
• Flexibility to work various shifts, as required.
• Flexible and willing to perform other tasks as assigned.
• Ability to lift up to 50 pounds, to and from a mobile cart, utilizing proper lifting and movement techniques. 
• Travel up to 10% may be required.

Work Environment                                                                                                                                          

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
• May be required to sit or stand for long periods of 8 hours a day while performing duties. 
• Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.