About:
Hilltop Bio was founded in 2018 to manufacture and distribute therapies that help injured animals repair damaged tissues and assist in restoring them to their full athletic potential and long-term health. Hilltop Bio focuses on science and the health and welfare of all animals.
The Opportunity:
The purpose of the Quality Assurance Coordinator is to be responsible for structuring and effectively implementing the quality system at Hilltop Biosciences. Compliance with established standards will be ensured through the involvement of various departments within Hilltop Biosciences and its external customers and suppliers.
The Quality Assurance Coordinator performs various activities associated with the quality management function, including assistance in auditing and training, network document control, and the release and implementation of standard operating procedures. This position also coordinates event management activities such as complaints and reporting discrepancies, performs and assists in root cause analysis and corrective and preventive action functions, and forwards this information to the appropriate management. The Quality Assurance Coordinator will also assist in developing and deploying a qualification system for supplies and reagents.
This position will report to the Operations Director for day-to-day direction and the CSO for Quality Strategy. Hilltop is based in Norwood MA. This position is in-person only, and you will be required to work from the offices in Norwood, MA. Hilltop Bio is willing to consider some flexibility in working hours.
As part of our team, your core responsibilities will be:
- Devising Hilltop Biosciences quality policies and procedures, Quality System implementation, process improvement programs, audits, validation, and CAPAs (corrective action and preventive action).
- Maintaining a document control and change management system.
- Monitoring the Hilltop Biosciences quality system to determine where improvements are needed and recommending appropriate corrective actions.
- Staying apprised of the latest regulatory requirements and implementing the necessary policies and procedures to ensure compliance.
- Reviewing compliance to the established quality system through internal and external audits.
- Developing and managing quality assurance programs used within Hilltop Biosciences and its external customers and suppliers.
- Conducting ongoing review, strategy development, and operational planning to ensure that all quality assurance programs meet applicable regulations and standards.
- Collaborating with organizational leadership in the establishment of quality assurance objectives on an annual basis.
- Ensuring internal projects meet Hilltop Biosciences' quality standards
- Ensuring contractual deliverables meet the satisfaction of each customer.
- Assist in developing and maintaining training program requirements in conjunction with Operations to ensure compliance with the program SOPs to maintain Hilltop Biosciences' quality expectations.
- Provide Hilltop Biosciences with regulatory and accreditation support. Assist in the management of FDA registration and act as the representative for all regulatory licensure activities.
- Facilitate and coordinate Root Cause Analysis, Statistical Process Control, and Corrective and Preventive Action activities as directed by senior management.
- Assist in designing, deploying, and continuously monitoring a reagent and supply / supplier qualification system.
- Capable of manufacturing and medical records review and interpretation (serology/microbiology results, histology reports, diagnostic exams, blood test results, etc.) as it relates to donor eligibility determination and final product release to distribution.
- Primary contact for customer complaints and resolution.
Note: The above responsibilities are standard functions associated with this position; however, they may not be all-encompassing. Other duties may be necessary, as defined by Management, for the efficient operation of the organization and its processes on a day-to-day basis.
Requirements:
- A bachelor's degree in a life science discipline is required, formal medical training or medical terminology training a plus. Equivalent experience may be accepted.
- A minimum of three (3) years' related work experience.
- Demonstrated knowledge and understanding of equine and canine anatomy including ocular, connective tissue, and musculoskeletal systems a plus.
- Ability to read and interpret documents, such as procedures, standards, regulations, etc.
- Knowledge of Root Cause Analysis, Statistical Process Control and Corrective and Preventive Action tools a plus.
- Working knowledge of standard Microsoft Office and Google applications.
- High degree of motivation, professionalism, and integrity along with the ability to work in an unstructured environment.
Qualifications
Baseline skills/experiences/attributes:
- Presents a professional image when performing position functions.
- Excellent verbal and written communication skills.
- Attentive to details.
- Able to work independently with minimal instruction or supervision.
- Demonstrates independence by prioritizing and completing assignments and is result-oriented.
- High level of ethical practice and confidentiality.
You Identify with Hilltop Bio's Core Values
- Team Oriented- you actively seek to help your team succeed and jump in when needed
- Efficient - you enjoy meeting and exceeding your tasks quickly and efficiently.
- Avid Learner - you are thoughtful & inquisitive; you question the status quo and find solutions to questions that haven't been asked
- Humble and Daring – No task is too big or too small
- Kind and Inclusive – You treat others as you wish to be treated with support, encouragement, and positivity
Benefits and perks:
- Comprehensive benefits packages
- 401k
- Flexibility in hours
- Friendly work environment alongside many other healthcare start-ups
Relocation benefits are not provided for this role.
Hilltop Bioscience is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.