Analyst I, Quality Assurance

 
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Quality AssuranceAnalyst I, reports to the Manager of Quality by ensuring the primary objective of batch record review and on the floor activities are effective and in compliance with regulatory requirements    
Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
-Batch Record Review 
-Review all batch documentation in accordance to governing procedures. This includes but is not limited to commercial and clinical manufacturing, Tech Transfer and Engineering runs. 
-Resolve errors and/or discrepancies in a timely manner and ensure appropriate action is taken. 
-Escalate any concerns or potential non-conformances to Supervisor and/or Manager 
-Compile and collate batch documentation packages 
-Prepare Release Protocols for submission to regulatory agencies 
-Perform ERP transactions associated with lot release; physically identify lot status 
-Commercial Product Distribution 
-Review shipment documentation in accordance to governing procedures. This includes shipments pertaining to commercial (licensed) distribution and excludes all clinical and unlicensed shipments. 
-Ensure all requirements have been met for QA release of the product shipment. This includes but is not limited to review against applicable Quality Agreements and/or contracts associated with the shipment. In addition, ensuring there are no regulatory restrictions on the product being shipped. 
-Other Activities: 
-Floor QA activities – monitor production, quality control and other support areas for compliance with procedures and GMP
-Support coverage of operational activities outside of core working hours
-Act as QA representative on project teams and/or meetings, as required. 
-Aid in the preparation of Quality Systems reports; this includes but is not limited to providing information on metrics. 
-Assist in the preparation and collating of information in support of audits and customer/regulatory inspections. 
-Perform other tasks as assigned.
The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
•    Minimum- B.Sc. Degree in Science, Pharmacy, Engineering or relevant college or technical diploma in chemistry/ biology/ biotechnology or High school diploma. 
•    Minimum- 2 years GXP related experience in the Pharmaceutical industry. 
•    Knowledge of FDA, Health Canada, and EMA GXP regulations, and the interpretation and application of these regulations to the work environment is preferred. 
•    The ability to be detail and goal oriented, focused on team work and the customer, prioritize and adapt to business needs as required. 
•    Excellent written and verbal communication skills are essential in addition to possessing the ability to work collaboratively as a team or independently. 
•    Capable of receiving detailed instructions on all routine work. 
•    Ability to perform simple problem solving and data analysis. 
As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.