QA Inspector Lead (11Pm -7:30Am)

Nature and Scope

This position is responsible for providing Quality oversight in manufacturing areas including, but not limited to Formulation, Filling, Inspection and Packaging through the execution of site policies and procedures, programs and work instructions. This position ensures all processes and products meet specifications and that products are produced in accordance with cGMP requirements. This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies. This position helps ensure compliance with of training requirements for inspectors. The Lead QA Inspector maintains compliance with quality programs. This position may initiate and author investigations as assigned by QA management.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Maintain quality objectives and conduct accurate verifications, including, but not limited to, identifying process and procedure gaps, reporting and escalating issues, developing corrective actions, sampling plans, accurate process inspections.

• Identify out of specification product, ensuring segregation and escalation, as required.

• Partner with personnel to resolve errors and/or discrepancies according to SOP requirements. Represent QA at cross-functional meetings.

• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.

• Partner with other departments to implement timely procedure changes, based on predetermined specifications, involving raw materials/finished goods and resolve compliance issues.

• Assist QA management with on the floor quality decisions regarding products and processes.

• Perform releases of sterilization equipment.

• Participate in Media Fills and maintain sterile gown qualification.

• Lead QA Inspectors in the support of the operations: including scheduling, training, coaching and mentoring.

• May conduct informal QA cGMP and housekeeping audits where applicable.

• May Author/edit SOPs and Investigations.

• Generate NextDocs Forms and Protocols.

• Designated QA representative for site operations cross-functional meetings (issue resolution), as needed.

• Evaluate non-routine data, interpreting specifications and exercising sound judgment for quality decisions regarding product (i.e. attributes, functionality, etc.), and effectively communicate orally and in written format, and provide recommendations and conclusions.

• Compile/review documentation for Annual Product Review.

• Drive quality process improvements and champion projects as assigned by Quality Management.

• Resolve quality issues, in conjunction with QA management as necessary, including deviations, memos, investigations, and CAPAs, generating final reports and utilizing technical expertise to support floor operations.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

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.

• High School or GED diploma required; Bachelor's Degree or equivalent years of experience preferred

• At least four (4) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) required

• Minimum one year prior experience in a leadership role preferred.

• Basic knowledge of cGMPs and supporting regulatory documents and apply appropriately

• Experience in QA working in a cGMP manufacturing environment required.

• Knowledge and demonstrated understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc

• Strong attention to detail, adherence to SOPs, and demonstrated practical application.

• Demonstrated ability to work effectively in a collaborative environment.

• Demonstrated ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results.

• Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues.

• Strong conflict resolution skills.

• Good presentation skills, suitable for management and cross-functional meetings.

• Strong PC Skills Required (MS Word, Excel). Working Knowledge of TrackWise.

• Ability to meet and maintain sterile gowning requirements.

• Demonstrable analytical thinking and problem solving skills.

• Ability to work overtime as needed.

• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected Hourly Rate:

$28.00 - $30.00

The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.