Job Summary
The Quality Senior Specialist provides site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in document review applicable to the respective processes executed at the respective lab, manufacturing facility, compliance, or regulatory team. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed. The Quality Senior Specialist demonstrates independent thought and applies practical troubleshooting and problem-solving with some supervision. The Quality Senior Specialist is a model to all other departments for adherence to GMP and regulations. The QA Sr. Specialist works on problems of basic scope in which analysis of situations or data requires a review of identifiable factors, exercises judgment within defined procedures and practices to determine appropriate action and escalates when needed.
On-Site Expectations
- 100% on-site position.
- Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am.
Responsibilities
- Performs quality review of complex documents, all types of data, protocols, and/or reports.
- Supports quality floor audits and/or floor inspections.
- Supports client and regulatory agency audits and inspections, as needed.
- Seeks to understand customer needs. Advocates for the client within the business unit.
- Identifies deficiencies that require action and supports customer decision making.
- Maintains quality databases and may perform analysis and trending.
- Assists with quality improvement initiatives as needed.
- Identifies and reports issues in a timely manner.
- Develops quality SOPs or other quality documents and/or reports as needed.
- Provides consultation on complex quality and compliance topics in areas of expertise.
- Develops and provides training in quality and compliance topics in areas of expertise.
- Understands Quality Management Systems including Investigations, Corrective Actions, Change Control, etc.
- Effectively performs a variety of complex duties, on schedule, with accuracy and competency.
- Maintains accurate files and records.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Responds to inquiries in a timely manner.
- Acts independently with support to conduct routine assignments.
- Works to master basic Quality business unit tasks applicable to the role with independent signature authority for these competencies.
- Effectively trains others.
- Other duties as assigned.
Qualifications
- B.S./B.A./M.S. in a related field with 8-12+ years relevant experience or equivalent.
- A.A.S. in a related field with 15+ years relevant experience or equivalent.
- Relevant GMP experience preferred.
Knowledge, Skills, and Abilities
- Experienced in several skills applicable to the functional area and demonstrates aptitude for continued learning.
- Able to comply with SOPs and regulatory compliance.
- Good knowledge of quality and regulatory concepts, principles, and procedures.
- Able to train others effectively.
- Excels in Right First Time.
- Actively and positively engages with team and supports process improvements.
- Works on moderately complex problems and applies practical problem-solving methods with minimal supervision.
- Requires detailed and specific instructions to complete assignments.
- Has mastered basic Quality business unit tasks applicable to the role.
- Strong computer skills including familiarity with computer software such as ERP, EDMS, Microsoft Word, PowerPoint, and Excel.
- Ability to take directions from experienced team members and contributes in a team environment.
- Effective team member; provides ideas, help, and support to teammates and peer groups.
- Good problem-solving skills.
- Good attention to detail.
- Can repeat and follow detailed scientific procedures with supervision.
- Able to clearly present results verbally in group meetings and in written progress reports.
- Good interpersonal skills and is willing to ask questions about procedures and concepts.
- Aptitude and willingness to gain more skills and knowledge in support of GMP regulations.
- Good written and verbal communication skills.
Travel Expectations
- Up to 5% travel required.
Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
