Lead QA Specialist
As we deliver our ambitious 2030 Growth Strategy, we're looking for a Lead 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, review of analytical data and relative documents, compiling reports, release of material and finished products, tracking and trending quality data, and timely escalation of quality events to management.
Who We're Looking For:
• Bachelor's Degree with a minimum of 6 years of experience in an applicable field or associate's degree with a minimum of 10 years of experience in an applicable field.
• Knowledge of cGMP preferred.
• Knowledge of FDA regulations preferred.
• Prior CAPA / Investigation oversight experience preferred.
• Experience in collecting, analyzing, and presenting data and recommendations to management.
• Effective written and verbal communication skills required.
• Proficient in basic applications such as Word, Excel, Outlook.
• High attention to detail.
• Good command of the English language.
• Intermediate math skills required.
• Excellent organizational ability.
• Work collaboratively with others.
• Ability to manage and lead projects assigned by QA Management.
• Able to manage multiple priorities and follow through on projects to completion.
• Ability to work well in a team-oriented environment.
What You'll Be Doing:
• 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.
• Provide new hire GMP training for employees.
• Other responsibilities that are outlined in one or more different Job Descriptions may be assigned.
Physical Demands: While performing the duties of this job, the employee is occasionally required to interact with other employees, customers, or vendors and must do so in a manner least obstructive to the conduct of business. The position is active and requires standing, walking, bending, kneeling, and stooping all day. This position requires the ability to climb stairs and lift approximately 50 lbs.
Work Environment: Requires the ability wear all required protective equipment including safety glasses. Employees must meet hygiene and health requirements.
What We Offer:
The successful candidate will receive a competitive salary and benefits package including:
• Excellent Medical, Dental, and Vision coverage, available immediately.
• Generous PTO
• 401K Match
• Wellness Reimbursement
• Parental Leave
• Career Development
• Company paid and voluntary Life and AD&D Insurance
• Short- and long-term disability
• Paid Holidays
Additional Information:
This is a site-based role located in Alabaster, AL.
If you require any reasonable adjustments during the hiring process or experience any issues with our online application process, please email [redacted].
