Quality Assurance Associate is responsible for investigating exceptions, complaints, conducting audits, revising documents, reviewing batch records, releasing of materials and conducting AQL inspection. Maintain routine programs and processes to ensure high quality product and compliance with current cGMPs.  Familiar with manufacturing and quality operations.  Ability to effectively prioritize, multitask and manage a varied workload is an essential function of this position.      

• Support QA Operations activities for aseptic filled products.

• Review documentation for equipment, utility, area release, batch release, and facility shutdown and startup.

• Support Quality Investigations of cGMP products as required.

• Support Exception Reports, Change Controls and CAPA reports as required.

• Develop SOPs and support continuous improvement initiatives.

• Perform maintenance and closure activities of documents such as reports, exceptions, CAPAs, change controls and complaints.

• Identify, investigate, and prepare reports on quality issues.

• Maintain effective communication and partnership with other departments.

• Maintain relevant training.

• Perform additional assignments as directed by the Manager.

• Support department to meet corporate goals and department objectives.

• Collaborate with other departments to address issues and meet deadlines.

• Support regulatory filing and Audits/FDA/Regulatory inspection activities.

• Participate in project teams.

• Provide support for internal audits.

• Ensure the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Able to lift, push, pull and carry up to 20 lbs. Other duties, responsibilities and qualifications may be required and/or assigned as necessary.

 Education, Experience and Skills: BS/BA in Life Science, Engineering or combination of experience and training. Minimum 0-4 years of pharmaceutical experience. Must have aseptic experience in pharmaceutical and biopharmaceutical industry. Excellent verbal, written and interpersonal communication skills. Ability to work in a face paced environment with changing priorities. Strong attention to detail and organizational skills.