Quality Operations Specialist II

2 months ago

Cumberland, United States NEUROTECH U S A Full time
Job DescriptionJob Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for treatment of a variety of retinal disorders. Our most advanced program is developing a treatment for the orphan disease Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform is designed to deliver a genetically modified neuroprotective factor to slow the progression of this chronic retinal disease.

We are seeking a Quality Assurance lead on Validation support and review. In addition, this role will assist on batch release activities for lot manufacturing, packaging, and associated non batch specific activities for the Cumberland, RI site. Additionally, the quality operations specialist will provide guidance and expertise for implementation of practical process improvements and continuous improvement initiatives.

This position is located in Cumberland, Rhode Island. This is not a remote or hybrid opportunity.

Please note, this role is not eligible for agency recruiting support. Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

Job Requirements

  • Provide full-time oversight to the validation program which includes providing validation program expertise, documentation review, validation strategy, etc.
  • To provide technical expertise and guidance in validation approach and documentation relating to expectations from NT Quality Assurance.
  • Perform regular quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as the need arises by site procedures and cGMPs.
  • Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance.
  • Helps to develop our quality culture and environment by aiding personnel in understanding application of policies and controls.
  • Participates in rapid response and provides quality guidance for deviation events.
  • Performs quality review and approval of procedures, training documents, deviations, CAPAs and change control and forms minor to major impact.
  • Participates, as needed, as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity.
  • Performs quality batch record and documentation review to allow release of Raw Materials and Product.
  • Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.

Education & Experience

  • Bachelor of Science or Engineering and 5-7 years relevant work experience within the cGMP Biotechnology and Medical Device industry.
  • May substitute proven experience for education requirement.
  • Experience in medical device and biotechnology field, preferably in the Quality and validation discipline.

Knowledge, Skills & Abilities

  • Success in this role will rely heavily on the candidate’s ability to articulate and teach quality principles to colleagues.
  • The ability to compromise and understand multiple points of view to solve complicated quality opportunities.
  • Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.
  • Knowledge in QMS management and support as well as significant GDP efficiency.
  • Ability to Manage multiple tasks and expectations and deliver on timely requirements.
  • Solid background in Quality Assurance/Systems including interpreting regulations, guidelines, and identification of compliance issues.
  • Experience in drafting audit reports and developing gap assessments and investigations.
  • Excellent communication skills, verbal and written.
  • Ability to work both independently with direction and within project teams to attain goals.
  • Proficiency in using multiple electronic software applications required to perform duties (MS Word, MS Excel, MS PowerPoint, Monday.com, SAP, Blue Mountain)

In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HSA & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. We even cover the cost of 75% of your annual medical plan deductible And that’s just the beginning.

Do you share our vision?

Applications are currently being accepted through the Neurotech Career Center.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Please note, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

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