Surterra is looking for a detail-oriented Quality Assurance Compliance Specialist for our manufacturing team. Responsibilities will include managing documentation of key processes, auditing processes for compliance with existing SOPs, reviewing quality controls and preparing for annual audits. Using our “Six Characteristics” (detailed below) as a compass, our goal at every step in the process is to deliver superior products to our consumers. This leader will ensure compliance with all applicable regulations, enforcing quality standards, troubleshoot issues, nurturing their team, and governing Surterra production processes.
CORE JOB RESPONSIBILITIES
- Ensures new and existing documents are written in accordance with established documentation procedures and accurately present details of the product or process following cGMP, cGDP and cGLP.
- Facilitates any requests for additional information needed to complete/update current of future projects.
- Works with Lead Technicians and Supervisors to create and update SOPs
- Train new and existing employees on best practices
- Support the broader compliance function and participate in company-wide compliance initiatives
- Report and maintain key performance indicators for team that are in alignment with company goals and strategies
- Auditing existing processes for compliance with SOPs, update SOPs as necessary
- Review quality check points within the manufacturing group to ensure employees are maintaining quality standards established for each product and process
- Support annual auditing initiatives with third parties and government agencies
- Demonstrated business acumen; able to assess financial implications of decisions and actions
- Have a proven track record of delivering results, leading people, and driving improvement
QUALIFICATIONS AND JOB SKILLS REQUIREMENTS
- Solid foundation of knowledge and experience in large scale manufacturing.
- Excellent written, verbal, and interpersonal communication and time management skills.
- Professional demeanor and ability to interact at executive level with persuasiveness and confidence.
- Exceptional analytical skills in pertinent areas related to role.
- Bachelor’s Degree in Engineering, Computer Science, Math or other related technical field and/or Business Administration. Advanced degree in technology-related discipline and Business Administration preferred.
- Must be able to remain in a stationary position 50% of the time.
- Constantly operates a computer and other office productivity machinery
- The person in this position frequently communicates with other employees/customers. Must be able to exchange accurate information in these situations.
- Must be able to travel domestically and internationally up to 20% of the time
- Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
6 Core Values of a Surterra Employee
Integrity – We operate in a regulated and unchartered industry. Act and make decisions that stand up to scrutiny and reflect our position as a sophisticated, credible and respected leader. Be honest, trustworthy, dependable, and honorable. Demonstrate sound moral and ethical ways of interacting.
Collaboration – We are a collection of the best talent at all levels. Learn and grow from this diversity: welcome healthy debate and proactively seek other perspectives and points of view to find the best solution while not resting on consensus. Proactively ensure the right people have the right information at the right time. Work as a team vs. an individual performer.
Agility – We are growing incredibly fast in a new industry. Be open to change, be ready to pivot on the moment’s notice, and act with a sense of urgency to take advantage of opportunities. Then be ready to do it again. Quickly –and calmly -respond and adapt to the unexpected. Modify and streamline processes, find more efficient ways of doing your job. Work efficiently across markets, time zones, and functions.
Intentionality – Intentionality requires action –it makes your intentions happen. Good thoughts are meaningless without action. It is initiative directed by the purpose to move our business forward. Intentionality is doing things important to you, even when not easy. Transformational change happens with intentionally.
Alignment – Together, we must understand and believe in our vision, mission, business and team goals and priorities. When we make a decision, even when we don’t have consensus we all align behind that decision and execute. We don’t revisit decisions unless we have material new data or circumstances.
Accountability – Make the best proactive and reactive decisions given the available information and the wisest counsel. • Own your decisions, actions and outcomes, and promptly correct mistakes. • Be reliable, honor commitments and do not finger point, off-load responsibilities, or criticize co-workers. Look after co-workers and team’s success.