QA Associate II

Description:

The successful candidate will perform review of documents, records and procedures supporting disposition of clinical or commercial cGMP products and participate in cGMP operations, as assigned. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Contributes to the completion of specific programs and projects.

Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex tasks in creative and effective ways.

Normally receives no instruction on day-to-day work, general instructions on new assignments.

Individual contributor with no people management responsibilities.

Principal Responsibilities:

• Perform QA role to support cGMP production and testing operations

• Provide QA in plant support to support manufacturing operations

• Review executed batch production records to ensure compliance with approved procedures and cGMP expectations. Communicate and resolve discrepancies

• Compile or assist with managing lot files

• Review/Approve Direct Material (i.e., raw material, other) testing to ensure data accuracy, conformance to specifications and documentation standards

• Lead/Assist labeling efforts of materials (i.e., raw materials, other) for production

• Work with internal cross functional teams to resolve issues and identify corrective actions

• Review and Approve deviations, CAPA, and change controls. Monitor responsible open quality system records to closure

• Review cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet cGMP and internal standards

• Write and review Standard Operating Procedures as needed

• Assist with the reporting and/or presentation of department metrics

• Participate in audits: internal, external (vendor, partner), and regulatory inspections

• Other duties as requested.

Additional Skills & Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent with 2 years or more relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing, QC or QA

• Knowledge of cGMP and applicable FDA/international regulations

• Direct experience with plant operations, pharmaceutical/biotechnolog manufacturing and analytical testing a plus

• Experience working with clinical and/or commercial products

• Detail oriented team player with effective planning, organization, and execution skills

• Excellent communication skills with internal and external personnel essential

• Ability to work effectively at a fast pace with cross functional departments

• Innovative, proactive, and resourceful: committed to continuous improvement

• Ability to anticipate and mitigate challenges

• Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems

• Strong computer skills (i.e., Word, Excel)

• Ability to work occasional weekends, holidays or overtime, as needed

• Ability to lift up to 25 Pounds and gown into manufacturing plant

• Ability to travel domestically and/or internationally up to 10% of time

• Typically requires a minimum of 2 years of related experience with a Bachelor’s degree in a scientific discipline or equivalent.

Experience Level:

Intermediate Level