Analyst II, 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.

Job Summary

The Analyst II, Quality Assurance supports the Manager of QA Operations by ensuring the primary objective of batch record review and on the floor activities are effective and in compliance with regulatory requirements.

Responsibilities 

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. 

· Floor QA Activities

  ·  Monitor Production (Manufacturing, Filling, Packaging), Quality Control, Inventory Control and other support areas for compliance with procedures and GMP

  ·  Report compliance concerns to Manager QA Ops and appropriate area management

  ·  Investigate concerns and/or discrepancies and ensure appropriate action is taken.

  ·  Support coverage of operational activities outside of core working hours

· Batch Record Review

  ·  Review all batch documentation in accordance with governing procedures. This includes but is not limited to commercial and clinical manufacturing, Tech Transfer and Engineering runs.

  ·  Investigate any concerns and/or discrepancies and ensure appropriate action is taken

  ·  Compile and collate batch documentation packages

· Review of QC testing results to ensure specifications are met and applicable procedures have been followed

· Visual Inspection and Packaging oversight

  ·  Over inspect visual inspection, labeling and assembly operations

  ·  Sample and collect in-process and finished product samples; inspect and prepare samples for stability program, QC testing and regulatory lot release submission

  ·  Dispense and maintain control of all labels for packaging operations

  ·  Disposition all packaging defects and rejected materials

  ·  Supervise workflow and product flow for WIP areas to the packaging operation

  ·  Liaise with internal departments to ensure work schedules are on track

· Prepare Regulatory Lot Release Protocols

· Perform ERP Lot Maintenance and Quality Transfer functions associated with lot release

· Commercial and Clinical Product Distribution

  ·  Review shipment documentation in accordance with governing procedures. This includes but is not limited to shipments pertaining to commercial (licensed) distribution, clinical 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 lots being shipped.

· Perform Lookback Notification Batch Assessments 

· Act as QA representative on project teams and/or meetings.

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 Requirement

•    Bachelor of Science (B.Sc.) in Science, Pharmacy, Engineering, or a related discipline;
or a college or technical diploma in Chemistry, Biology, or Biotechnology;
or a high school diploma with a minimum of five (5) years of experience in a GXP-regulated pharmaceutical environment. 
•    Minimum- 5 years GXP related experience in the Pharmaceutical industry. 
•    Solid working knowledge of FDA, Health Canada, and EMA GXP regulations, and the interpretation and application of these regulations to the work environment. 
•    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.

•    This role requires the successful candidate to complete a pre-employment eye examination as a part of employment for this role, as well as annual eye exams throughout the duration of their employment. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

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.