Quality Assurance Specialist - Commercial Quality

The Quality Assurance Specialist position works with our Partners to ensure standards and requirements are met for routine product shipments and distributions.

Essential Duties and Responsibilities include the following. Other duties may be assigned.
•Performs review and approval of QA documentation for all batch disposition activities, including:
oBatch Record review per the applicable review frequency.
oReview of COA, COC, and Quality documentation supporting shipment authorization of product manufactured for prior to shipment.
oReview of Partner’s investigations for adequate root cause analysis.
oReview of temperature profiling data.
oDispositions product.
•Provide guidance and support in all aspects of cGMP to our Partners.
• Remains current in regulatory trends and requirements.

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

• Adapt to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated.
• Has a sense of urgency to meet all required deadlines.
• Ability to manage indirect relationships and projects successfully.
• Elevates issues to management, when appropriate.

Education and/or Experience
Bachelor's degree in life sciences from 4 year college or university; 1-3 years QA/QC experience in the pharmaceutical or related industry; or equivalent combination of education and experience; excellent knowledge of current GMP and GLP as well as FDA trends and guidelines; strong interpersonal skills and great attention to detail are necessary; background in aseptic processing, preferably with injectables, and experience with complex generics, drug-device combination productions, biosimilars, or biologics is a plus.

Travel No travel required.
Computer Skills Proficient in Microsoft Office, Adobe Systems (Pro, Acrobat DC) and Quality management systems (TrackWise) preferred but not required.
Physical Demands While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.

Work Environment The noise level in the work environment is usually moderate.

AAP/EEO Statement Equal Opportunity Employer Minorities/Women/Veterans/Disabled.