Quality Assurance Associate

JOB SUMMARY:

Under supervision, the Quality Assurance Associate supports and upholds quality assurance policies and procedures throughout the company in accordance with International Organization for Standardization (ISO) 9001:2015 standards, as well as select elements of Current Good Manufacturing Practice (cGMP) and select elements of International Council for Harmonization (ICH) quality guidelines. Primary responsibilities include material inspection/disposition and batch record review. Must be equally adept at operating within electronic and paper-based systems. Collaborates directly with cross-functional stakeholders and reports to the Quality Assurance Manager.

ESSENTIAL DUTIES and/or RESPONSIBILITIES:

1. Inspects raw materials and packaging components. Verifies material identity and labeling. Issues applicable controlled Quality Control (QC) test records.


2. Issues controlled batch record documentation to the Production department. Attends daily production schedule related meetings to ensure timely QA support of production activities. Supports manufacturing activities through the performance of line clearance.


3. Reviews completed raw material documentation, packaging component documentation, finished product batch record documentation, and associated QC test records for the purpose of rendering a final material or product disposition in accordance with applicable standards, procedures, and policies.


4. Supports order fulfillment through the performance of line clearance by reviewing, verifying, and conducting final review of product documentation and labels for customer delivery.


5. Prepares and releases raw material and finished product labels.


6. Assists with the controlled document change and revision process including submission through the eDMS, generation of redlines, providing justification for the change and ensuring proper approvals are obtained prior to implementation.


7. Photocopies, scans, and archives both electronic documents and hard copy documents, including, but not limited to, batch records, raw material records, and training records.


8. Issues, maintains, and reviews equipment logbooks and calibration and qualification records.


9. Participates in internal and external audits by providing administrative support to QA management.


10. Under supervision, assist with the initiation and documentation of quality events (e.g.: deviations, CAPA, change control, complaints).


11. Performs assigned tasks to meet established Key Performance Indicators.


12. Other duties as assigned.

SUPERVISORY RESPONSIBILITES:

1. N/A

MINIMUM EDUCATION and/or EXPERIENCE:

1. Bachelor’s degree in a scientific field with one (1) to two (2) years direct experience in a regulated manufacturing environment OR equivalent combination of education and experience.

KNOWLEDGE, SKILLS, and/or ABILITIES:

1. Exercises good judgement at all times and strictly complies with policies and procedures. Immediately reports deviations when detected.


2. Highly developed critical thinking and problem-solving skills. Ability to identify process issues and provide suitable solutions.


3. Robust multi-tasking skills with demonstrated ability to respond to rapid changes in priorities.


4. Strong ability to verbally communicate across functional groups and provide high-level customer service through effective interpersonal skills and conflict resolution.


5. Intermediate level of experience operating Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as Net Suite, etc.


6. Advanced reading skills with the ability to analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations.


7. Clear and succinct writing skills with the ability to draft reports and present technical information in understandable terms and respond to questions from both internal and external customers.


8. Effective as an individual contributor as well as a team member. Fosters cooperation and collaboration in a team environment.


9. Comfortable in a detail-oriented environment with strong follow-up, follow-through, and organizational skills.


10. Direct experience in an ISO 9001:2015 certified manufacturing environment, a plus.

CERTIFICATES and/or LICENSES:

1. N/A