QA Specialist

Croda International•Alabaster, AL

4d•Onsite

About The Position

QA Specialist Croda is a FTSE 100 organisation where we truly believe our people are our difference and this, along with our values of Innovative, Responsible and Together, creates ‘our Purpose, Smart science to improve lives™’. With over 5,000 employees globally, we specialise in the research and development of innovative ingredients for the Life Science and Consumer Care markets. We are focused on developing our inclusive culture through accountability, collaboration and innovation. By joining Croda, you will be part of a team who are using smart science to create a more sustainable future. As we deliver our ambitious 2030 Growth Strategy, we’re looking for a QA Specialist, responsible for performing duties and functions relative to maintenance of document control of GMP documents in support of Quality Assurance Division functions such as creation of documents, release of material and finished products, tracking and trending quality data, and timely escalation of quality events to management. 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

Requirements

Bachelor’s Degree required in the field of natural sciences, engineer or management preferred.
Minimum of 10-19 years’ experience in quality or operations, primarily in a cGMP environment.
Pharmaceutical operations experience and/or knowledge required.
Good knowledge of FDA regulations.
Prior CAPA / Investigation oversight experience preferred.
Experience in collecting, analyzing, and presenting data and recommendations to management.

Responsibilities

Perform Document Control for Batch Production Records (BPRs), Standard Operating Procedures (SOPs), Raw Material (RM), Avanti Product (AP) specifications and Job Descriptions.
Conduct product releases/rejections including review of batch production documents, review of analytical results, and comparison to specifications.
May be tasked with the design, development and delivery of high quality and high impact training programs and services that provide functional, GMP and product knowledge for employees to achieve a high level of performance in their jobs.
Implement and follow the Corrective and Preventive Action Program (CAPA) process to ensure effective and timely closure of CAPAs.
Oversight of Facility / Equipment qualification.
May be required to help develop and/or review/approve User Requirements Specifications, as well as IQ/OQ/DQ documents.
Conduct Annual Product Review.
Provide QA input for product shipments including product release, label preparation, review and application, final label review, shipment packaging, and shipment paperwork.
Write and revise BPRs, SOPs, RM specs, AP specs and Job Descriptions on a timely basis.
Perform annual document reviews (when required by quality systems).
Perform internal audits.
Conduct raw material qualification and vendor management.
Prepare for and assist during customer / FDA audits.
Review / Approve Out-of-Specification (OOS) documentation.
Perform Change Control (review and approval of Deviations and Change Requests).
Perform process / method validation program (including design and review of validation efforts).
May maintain or assist in the maintenance of calibration and maintenance database for equipment to ensure that equipment and instruments are fit for use.
Keep personal training up to date using Quality Management tools provided.
Follow all written policies delivered by Management and/or Regulatory Affairs (Standard Operating Procedures, Chemical Hygiene Plan, Emergency Contingency Plan, training memoranda, policy memoranda, Material Safety Data Sheets, Specification Records, etc.).
Generate quality metrics using specific systems/applications by obtaining raw data, developing quality monitoring database and creating appropriate level reports using MS Excel (pivot tables, charts, graphs, etc.) or other software (MasterControl).
Perform or participate in investigations using various tools such as root cause analysis, Failure Mode and Effects Analysis, etc.
Assess causes systemically, looking beyond the obvious to determine why people, processes and/or systems are not meeting quality standards.
Analyze resulting quality metrics and assess trends.
Work with supervisors of departments to ensure consistency and close gaps in coaching and training.
Provide ongoing analysis of data resulting from the quality systems review.
Communicate results of analysis to management.
Assist GMP work areas in developing, implementing, and maintaining On-the-Job Training (OJT) programs.
Expected to assist in the development of junior colleagues and as assigned by QA Management, take leadership on special projects and routine activities.
Provide new hire GMP training for employees.
Other responsibilities that are outlined in one or more different Job Descriptions may be assigned.