Job details
Salary $75,000 - $120,000 a year job type full-time number of hires for this role 1
Qualifications
Quality control in pharma: 5 years (required)
Bachelor`s (preferred)
Full job description
Reports to: vice president quality systems
Company overview:
Sq innovation is a privately held swiss biopharmaceutical company located in burlington, ma and zug, switzerlandThe company was established to develop and commercialize innovative cost-effective therapies for subcutaneous delivery of pharmaceutical productsIts first product, for the treatment of fluid overload (edema) in patients with heart failure, is currently under development following a plan that has been reviewed with the us-fdaThe novel combination product is based on the sensile medical micro-pump technology and its small-volume cartridge-based platformThe device design uses a reusable motorized component and disposable cartridge, which minimizes waste and creates cost-effective treatment options in numerous therapy areas, including treatment of edema in heart failureThe company is pursuing a 505(b)(2) nda for the drug-device combination.
Job overview:
Development, manufacture and distribution of clinical and commercial combination product(s)Ensuring the company, its affiliates and/or contractors associated with manufacture, packaging, labeling, testing and distribution of product(s) used for investigational clinical trials through commercial phases comply with cgmps and applicable regulations.
Responsibilities and duties:
Provide oversight of external contract manufacturing organizations and testing laboratories;
Support product release activities for starting materials, intermediates, api, drug product, and finished goods including batch records reviews;
Support gmp investigations, capa, and change management actions;
Assist in preparing cmc sections of regulatory submissions;
Support gmp supplier qualification by assisting with audits;
Assess and approve iq/oq/pq documentation for new equipment, as required, as well as validation documentation (i.e., protocols, reports) in support of new drug products, packaging and devices that are to be introduced;
Perform audits on an as need basis;
Oversee and manage the stability program including review and approval of test results, statistical evaluation of the timepoint data, establishing, extending retest dates, predicting expiration dates, and preparation of summary reports;
Assess and directly work to continuously improve quality processes at sqi;
Support overall gxp compliance and readiness for health authority inspections;
Review all pharmaceutical development, device and packaging documentation for clarification and correctness;
Works cooperatively with device companies to receive correct data and references;
Writes and reviews reports for health authorities.
Qualifications:
Education level:
Bs in chemistry, analytical chemistry, pharmacy or equivalent field; or the equivalent combination of education and experience.
Experience:
Five years of quality control experience in the pharmaceutical industry including a minimum of two years of quality assurance experience;
Experience working with contract manufacturing organizations and contract testing laboratories; knowledge of cgmp regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, packaging and qc testing, and final product release.
Specific skills:
Demonstrated ability to work independently, as well as in a team environment;
Demonstrated problem solving skills by assessing complex issues, breaking into components, and proposing solutions;
Excellent communication and listening skills, both verbal and written;
Must be proficient in using basic software applications including microsoft office (word - generate documents and tables, excel - able to create and modify spreadsheets, create complex formulas, etc.).
Personal characteristics:
Proven organizational skills;
Ability to be pro-active and be self-motivated to resolve issues before escalation;
Ability to work in a team environment and adapt to changing plans and circumstances;
Ability to handle multiple projects and priorities simultaneously in a fast-paced environment;
Strong communication skills;
Strong problem solving and decision-making skills;
Strong attention to detail.
Physical abilities:
Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day;
Ability to frequently and accurately communicate with customers and management face-to-face, via the telephone or by email;
Ability to travel both domestically and internationally.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job type: full-time
Pay: $75,000.00 - $120,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Retirement plan
Vision insurance
Schedule:
8 hour shift
Monday to friday
Application question(s):
Do you have five years of quality control experience in the pharmaceutical industry including a minimum of two years of quality assurance experience?
Do you have experience working with contract manufacturing organizations and contract testing laboratories; knowledge of cgmp regulations, practices and trends pertaining to pharmaceutical product development manufacturing, packaging and qc testing, and final product release?
Education:
Bachelor`s (preferred)
Experience:
Quality control in pharma: 5 years (required)
Willingness to travel:
25% (preferred)
Work location:
One location
Work remotely:
Yes
Work location: one location
