JOB SUMMARY: Ensures that services adhere to the company’s quality standards. Responsible for developing quality inspection procedures and implementing inspection activities that detect and resolve product or service defects. The Senior QA Specialist must have a detailed in-depth knowledge of quality systems including; documentation control, training, deviations, CAPA, complaints, validation, audits, change control, calibrations and supplier management. The Senior QA Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes and controls.
DUTIES AND RESPONSILITIES:
- Oversee the generation, review, approval, and archival of controlled documents used to support GxP operations. Ensure consistency and compliance to formatting and template requirements.
- Writing and revising standard operating procedures (SOPs).
- Maintain controlled documentation archive.
- Ensure systems are in compliance with current SOPs and pharmaceutical industry and hazardous waste laws & regulations.
- Leadership and participation in QA operational activities, including: change controls, non-conformance/deviation investigations, complaints, CAPA, CAPA effectiveness check, validation of equipment & software, internal and external audits, & approving GxP operations suppliers.
- Lead and participate in Lean process improvement projects.
- Lead and coordinate testing efforts for complex projects.
- Mentor and provide guidance to junior QA and QC team members.
- Lead and conduct both external and internal audits to ensure compliance with GMP, FDA, EPA and other regulatory requirements.
- Maintain inspection readiness and lead or participate in external and regulatory audits.
- Perform review and approval of deviations and nonconformance as required.
- Assist investigations and resolve potential service & product quality issues to improve efficiency.
- Implement, monitor, and record all corrective and preventive actions taken.
- Perform, review, approve, and record risk management assessments for deviations, validation, supplier management and other processes as required.
- Create, review and approve validation plans and protocols (IQ/OQ/PQ) for GxP computer systems and equipment.
- Support the establishment and periodic review of the Quality Management System (QMS).
- Manage quality projects as requested by Management and role.
- Maintain schedules and coordinate activities for project efforts.
- Evaluate procedures and coordinate with subject matter experts to identify areas of quality and process improvement.
- Develop and maintain positive relationships with other departments and management.
- Conduct training sessions on quality assurance processes and regulatory requirements.
- Facilitate continuous improvement through the development of training programs and materials.
- May perform additional duties as required.
BENEFITS:
- Medical, Dental, Vision, STD, LTD, and additional benefits
- 16 paid time off days in your first year of employment increase to 22 at 1 year.
- 401(k) matching
Requirements
JOB REQUIREMENTS / QUALIFICATIONS:
- Excellent verbal and written communication skills.
- Excellent organizational and analytical skills and attention to detail.
- Ability to take complex, technical information and translate it for colleagues and consumers who have nontechnical backgrounds.
- Proficient in cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211 and 820.
- Five to eight years of experience in the pharmaceutical or medical device industry.
- Experience leading internal and external audits
- Leadership and mentoring abilities
- Ability to meet deadlines and to work independently.
- Ability to work as part of a team.
- Decision-making skills.
- Proficient with Microsoft Office Suite or related software.
PHYSICAL REQUIREMENTS:
- Prolonged periods sitting at a desk and working on a computer.
DESIRED KNOWLEDGE / SKILLS:
- Bachelor’s, or higher, degree in a scientific discipline.
- Previous experience in a pharmaceutical reverse distribution environment.
- Lean Six Sigma green belt or higher.
- Knowledge of DEA / EPA regulations as they pertain to a reverse distribution company.
Salary Description
$60,000 - $73,000