ReciBioPharm, the biologics business unit of Recipharm AB, is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. ReciBioPharm’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives.
The Sr. Quality Assurance Operations Specialist will primarily be responsible for day-to-day quality operations’ activities by supporting manufacturing being on the floor during production. This highly motivated member of the Quality Unit will promote a culture of compliance throughout the organization through providing quality oversight on production batch record reviews, quality walkthroughs of GMP classified areas and review of exception documents such as Deviations, CAPAs and Change Controls. This Quality team member will be integral in building systems to support, track and close all production records and related exception documents in Arranta Bio Watertown site.
ESSENTIAL JOB FUNCTIONS
- Provide on-the-floor QA support for manufacturing activities by being present during the manufacturing runs and reviewing production documentation real time on the floor
- Issue production batch records, solution buffer records, test record and product labels to support manufacturing activities
- Actively participate in fostering a positive, collaborative work culture
- Ensuring adherence to cGMPs across the organization
- Collaborate with other departments and customers to ensure timely closure of production batch records
- Collaborate with other departments to ensure timely initiation and closure of Deviations, CAPAs and Change Controls
- Participate in customer meetings as needed to drive customer review and approval on production and exception documents
- Foster and develop intra- and inter-departmental relationships
- Support product disposition activities
- Provide support for internal and external audits including report generation
- Evaluate and mitigate program risk and escalate quality issues as needed
- Support quarterly quality management review meetings through preparing metrics
Experience and Skills
- Bachelor's degree in science or a life science-related field of study
- 8+ years of experience in Quality Assurance in GMP environment, preferably with a technical background
- Experienced in master and executed production record reviews
- Experienced in reviewing and approving exception documents such as deviations, OOS, change control and CAPAs
- Raw material and product disposition experience is desirable
- Strong knowledge of FDA, ICH, and EU GxP Regulations and Guidelines
- Experience with ensuring alignment with relevant guidance and regulations
- Involvement in risk assessment
- Management of major and critical investigations, complaints, and CAPAs
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to read and interpret documents such as SOP’s and Work Instructions.
- Ability to speak effectively before groups of employees in the organization.
- Ability to apply common sense understanding to carry out instructions furnished in written or oral form.
- While performing the duties of this job, the employee is required to sit and work at a computer for extended periods of time.
- Is regularly required to talk and hear.
- The employee frequently is required to be mobile and able to independently transport themselves between buildings, as dictated by the essential functions and responsibilities of the position.
- Work Environment This is an office-based position that may require some non-standard working hours including early morning or later evening teleconferences on weekdays and weekends to support global prospective and current clients.
Who We Are
ReciBioPharm hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at ReciBioPharm, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging. Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
- This position requires a criminal background check and drug screening.
- COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation.
ReciBioPharm offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
ReciBioPharm is an Equal Opportunity Employer.