Job Summary

The Quality Assurance Specialist II supports the day-to-day GMP manufacturing operation via execution of all operational elements of the Quality Assurance Operations, including but not limited to deviations, corrective and preventive actions (CAPAs), investigations, excursions, out of specifications (OOS), change control, batch record review and disposition, and training in support of biologics manufacturing production. He/She will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, Quality Control, Process and Analytical Development and customers to ensure cGMP compliance and establish a quality culture. This is a unique opportunity to help build and grow the QA Operations organization in a dynamic and fast-paced CDMO environment.

Essential Duties And Responsibilities

  • 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.
  • Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
  • Review and approve master batch records.
  • Perform the review and approval of product testing and environmental monitoring data.
  • Review and approve room cleaning documentation including environmental monitoring testing data to conduct room releases.
  • Review, assist in the investigation of environmental excursions.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Operations procedures.

Qualifications - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education And/Or Experience

  • BS required, MS preferred in a scientific/technical discipline with 5+ years of experience in a QA position within the biological and/or pharmaceutical industry.
  • Ability to apply GMP regulations and international guidelines to all aspects of the position
  • Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
  • Exceptional oral and written communication skills to all organization levels as well as clients and vendors
  • Strong organizational skills; able to prioritize and manage through complex processes/projects
  • Ability to write reports, business correspondence and SOPs
  • Ability to be hands-on and detail orientated
  • Very proficient in MS Office application suite as well GMP electronic applications

Language, Mathematical, And/Or Reasoning Ability

  • Effectively manages cross-functional communication
  • Multitasks, strategically and tactically in a fast-paced work environment
  • Strong organizational skills; able to prioritize and manage through complex
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Detail-oriented and highly motivated with excellent written and verbal communication skills required.
  • Ability to work independently and stay on task in a fast-paced environment
  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

Physical Demands

  • Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing – writing,
  • Ability to lift and carry 10 pounds
  • The ability to gown and work successfully in a manufacturing environment

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.

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,900 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.

Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.
For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com

URL to this pagehttps://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3311&rmlang=UK