Senior Quality Associate
The role of The Senior Quality Assurance Associate will support the company’s quality and regulatory systems in compliance with industry best practices. They will implement and maintain corporate and departmental procedures. This position will additionally serve as an integral member representing quality on cross functional teams and supports all functional areas with needs related to QMS documentation. This position reports to Vice President, Quality.
- Perform Quality Assurance activities to ensure compliance with internal processes and procedures and applicable US and international regulatory requirements in support of GMP and GCP procedures
- Review documentation for release of combination products including manufacturing batch records, executed Batch Records, certificates of analysis, stability protocols and reports, and specifications
- Management and Tracking of external Vendor Quality Events & CAPAs
- Coordinate the review, approval, issue and maintenance of QA controlled documents and records including SOPs, Templates, and Technical Reports
- Process internal deviations, investigations, CAPAs, and change controls
- Support regulatory inspections and inspection readiness activities for Quality Systems
- Willingness and ability to travel for training and support of external vendors and suppliers
- Other responsibilities and duties as assigned
Education and Experience Requirements:
- Bachelor’s Degree or equivalent combination of education and experience
- 2+ years of experience in a quality document management, quality assurance, or quality systems in pharmaceutical, bio-pharmaceutical, or medical device field. Strong knowledge of GXP, SOPs and quality system processes
- Experience in managing both internal and external records, quality-controlled documents, revision workflows and document change control processes. Experience with an electronic document management system is a plus
Skills and Abilities:
- Ability to coordinate and prioritize all areas of responsibility in a fast-paced environment
- Team oriented and adaptable with solution-oriented nature
- Excellent written and oral communication skills
- Exceptional organizational and time management skills with the ability to confidently multi-task
- Strong, proactive problem-solving skills, detail oriented
- Self-directed with an “ownership” mindset
- Accountability: You… See it. Own it. Solve it. Do it. You possess a high degree of personal responsibility with a similar expectation of your team and colleagues.
- Commitment to Patients: You have a passion for creating strategic, innovative, valuable, and high-quality solutions and products with a hands-on approach.
- Teamwork: You confer with others to reach resolutions that are acceptable by all parties involved. You can multi-task and productively manage complex situations involving cross functional teams.
- Integrity: You possess and demonstrate a high level of emotional intelligence and professionalism in your decision making. You unfailingly act with integrity and respect for colleagues, business partners and customers in all business dealings.
- Value Driven: You produce consistent, high quality and quantity of outputs and meaningful results that contribute to strategic goals.
- Empowered Communications: You possess and demonstrate strong communication and interpersonal skills.
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.