- Develop, implement, and oversee QC stability testing SOP, Master Plans, Protocols, Reports.
- Generate comprehensive stability reports with statistical analysis summaries.
- Oversee the product and material retain programs for Quality Control, ensuring that appropriate documentation is maintained, and that periodic inspections are performed.
- Provide operational support of the site reference standard management program.
- Conduct laboratory investigations, including OOS, Out-of-Trend, and deviations. Identify root cause and recommend and implement corrective actions.
- Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain Quality Control systems and activities.
- Participate in internal and external GMP audits, as needed.
- Assist in the implementation of and managing the sample and result of data into automated LIMS.
- Become a subject matter expert in one or more areas of required testing.
- Executes daily activities in routine sampling raw materials, testing of raw materials and lab maintenance.
- Assist in the implementation of and managing the sample and result of raw materials data into automated LIMS.
- Coordinate and communicate with third parties and/or other departments.
- Ships samples and monitors test results produced by contract testing laboratories.
- Participates in raw material testing equipment and instrument qualification, calibration, and preventive maintenance.
- Coordinate and communicate with third parties and/or other departments to ensure completion of tasks.
- Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities around raw materials.
- Train other junior level analysts and new hires.
- Bachelor's Degree or above in Chemistry, Biochemistry, Microbiology, or Biotechnology related scientific discipline.
- A minimum of 5 years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
- Experience in a pharmaceutical cGMP environment.
- Proficiency in statistical software (e.g., JMP, Minitab) preferred.
- Proficiency in using LIMS software.
- Working knowledge with USP/EP, ICH Guidelines and cGMP/EU GMP.
- Familiar with instrument and equipment validation.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Hands-on approach, with a 'can do' attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
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QC Raw Materials - Cumberland, United States - NEUROTECH U S A
1 week ago
Description
Job Description
Job DescriptionNeurotech 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 currently seeking a QC Raw Materials & Stability Analyst III to join our Quality team. This is a dual function comprising of responsibilities in both the Stability and Raw Materials functions. The Specialist will perform routine sampling, inspection, and release testing of raw materials per USP/EP/standard methods, perform testing to support method verification/validation and material/supplier qualification and author said studies and corresponding reports.
Additionally, the Analyst III will oversee the execution of Neurotech's GMP Stability program and establish governing documents that monitor and assess the performance of materials over time (e.g., drug substance, drug product, raw materials, reference standards). The individual will routinely apply statistical data analysis using QC test results to support shelf life.
This is an on-site role in Cumberland, RI. This is not a hybrid or remote opportunity.
Also, please note this role is not eligible for agency recruiting support.
Job Requirements
Education & Experience
Knowledge, Skills & Abilities
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.
