The role of The Quality Associate will support the company’s quality and regulatory systems in compliance with industry best practices. They will primarily support the Product Complaint Handling process.
This position reports to the Quality Director.
Responsibilities:
- 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 incoming product quality complaints and investigate complaints in Product Complaint Summary Reports
- Review incoming adverse event reports and investigate qualifying cases in AE Investigation Summary Reports
- Collaborate with the Investigation teams at applicable CMO’s to reconcile, investigate, and complete returned product investigation reports
- Support third-party decontamination services as needed
- Maintain the Complaints SharePoint site, Complaint Handling documents, and Batch Record Review documentation
- Support Product Complaint, return shipment, and return investigation trending activities
- Support improvements to process and procedures related to Product Complaint intake and handling
- Support review, approval, issue and maintenance of QA controlled documents and records including SOPs, Templates, and Work Instructions related to the Product Complaint handling process.
- Support internal deviations, investigations, CAPAs, and change controls as needed.
- Willingness and ability to travel for training and support of external vendors and suppliers.
- Other responsibilities and duties as assigned.
Required Expertise Competencies:
- Bachelor’s Degree or equivalent combination of education and experience.
- 1+ years of experience in a quality document management, quality assurance, or quality systems in pharmaceutical, bio-pharmaceutical, or medical device field. Intermediate knowledge of GXP, SOPs and quality system processes preferred.
- Experience with JMP statistical analysis software is preferred.
Required Power Competencies:
- Teamwork & Leadership: Excellent team member who consistently follows through on commitments with quality work; demonstrates solid knowledge of function; demonstrates solid and growing communication skills.
- Execution: Action-oriented with a sense of urgency to deliver high quality work; individually accountable for consistent results.
- Solution Maker: Dissects individual work/process issues to discover opportunities for improvement and then provides a solution.
- Continuous Improvement: Commitment to growth mindset; open to new ways to learn and be challenged; student of profession.
- Awareness: Develops awareness and understanding of personal strengths and limitations; demonstrates awareness of situational cues and changing circumstances; gains confidence and trust of others.
- 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.
Expectations:
- This position is hybrid with a minimum of two days per week in our Burlington, MA office, between Tuesday and Thursday. Additional time in the office could be required as circumstances dictate.
EEO Statement
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. It is the Company’s policy and intent to provide equal opportunity in employment, development and advancement without regard to a race, color, religious creed, sex, pregnancy, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, ancestry, military service or veteran status, marital status or any other category protected under applicable federal, state or local law.
