Quality Lead

Quality Lead

Summary:

The Quality Lead monitors and guides Quality Inspectors while providing quality support to the packaging area, including oversight for adherence to cGMPs, FDA, and DEA compliance. The Quality Lead serves as a practitioner who applies Quality Assurance disciplines - analyzing product quality to ensure conformance to specifications and established plans - as well as Quality Control responsibilities, including daily monitoring, controlling, and reporting on quality across all phases of production, and packaging.

General Duties and Responsibilities:

• Adheres to proper cGMP's including good housekeeping, proper protection of product quality and integrity, and personal hygiene.
• Reads and understands written instructions and SOPs.
• Knows and understands quality-related SOP requirements that determine appropriate process for conducting job performance.
• Knows and understands applicable regulatory requirements that impact job performance.
• Makes sure relevant activities fall within SOP and regulatory requirements to ensure product conformity.
• Prioritizes multiple tasks simultaneously and completes tasks in a timely manner.
• Monitors and guides Quality Inspectors to ensure adherence to cGMPs, SOPs, and regulatory requirements.
• Provides appropriate information regarding quality activity and requirements in response to packaging personnel questions.
• Rejects products that do not conform to required specifications and follows up on any requirements to obtain product conformance.
• Responds to, investigates, and tracks product complaints.
• Trains new Quality Inspector personnel.
• Acts as an informational resource for Quality Inspector I personnel.
• Reviews Batch Record for accuracy prior to packaging run.
• Checks, verifies, corrects, and approves product, labeling, and component quality integrity and quantities for production.
• Checks product lot number information.
• Reviews outserts and product sample for accuracy.
• Reviews and approves case labels for accuracy.
• Issues correct labels for production run and quantity.
• Conducts line verifications.
• Conducts product in-process inspections.
• Performs final QA inspection for final product release.
• Verifies product, component, and labeling reconciliation accuracy during final product release.
• Inspects Packaging Room Clean/Clear status and approves its use for next packaging run.
• Receives product, component, and label inventory (review/verify information; data input).
• Reconciles label inventory sheets.
• Performs quality duties as assigned.

Supervision:

Received: Directives from Supervisor, Quality.

Given: None.

Equipment:

Standard office equipment, computers, full-body suit, lab coats, goggles, cap, booties, respirator, gloves, and general warehouse safety equipment.

Physical/Cognitive Requirements:

• One to three years of experience in pharmaceutical manufacturing is preferred.
• Quality auditing experience is required, either in Quality Assurance or Quality Control.
• Knowledge of federal and state laws, regulations, and accreditation standards.
• Thorough knowledge of quality system regulations and requirements, including ISO (International Organization for Standardization), FDA (Food and Drug Administration), and GMP (Good Manufacturing Practices).
• Knowledge of manufacturing processes and relevant statistical techniques, including Six Sigma and Statistical Process Control (SPC).
• Effective communication skills at all levels, both written and verbal.
• Effective skills in analytical thinking and problem solving.
• Ability to perform multiple tasks and effectively manage conflict.
• Ability to work in teams to obtain results.
• Works independently on assigned projects with moderate supervision; proactively seeks guidance on complex or ambiguous tasks.
• Time management and planning skills are essential, as well as excellent interpersonal skills.
• Excellent computer skills and strong internet research skills are required.
• Must have the ability to adapt to work through conflicts and persuasively influence outcomes.
• Can effectively cope with change and is comfortable changing direction and acting without complete information.
• Ability to develop and deliver effective presentations and written/oral communications.
• Strong organizational and prioritization skills.
• Team player; works with others effectively, respectfully, and cordially.
• Identifies root causes and executes plans to resolve moderately complex problems with limited supervision.
• Capable of resolving moderately sensitive concerns that present manageable risk to the business.
• Job involves extended periods of sitting and reading and analyzing information.
• May be required to work longer than the typical 8-hour workday.
• Regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Perform light physical duties in keeping personal workstation clean, organized, and presentable.

Education, Training, Skills, and Experience Requirements:

• Must have working knowledge of basic PC software: Excel, MS Word, PowerPoint, etc.
• High School Diploma or equivalent.
• Must have good English written and verbal communication skills.
• Good arithmetic skills are required.
• Working knowledge of measurement instruments.
• Must be able to obtain forklift license.
• Must be able to effectively research, compile, sort, and present information and reports.

Miscellaneous Requirements:

• Maintain a strong attendance record.
• Must be able to pass screening, drug test, and background check.
• Adhere to company's drug-free workplace policies.
• Knowledge of computer equipment set-up.
• Skill in using precision tools.

Attitude:

• Demonstrates a positive, dependable, and professional approach to daily responsibilities.
• Communicates clearly and respectfully with supervisors, management, and team members.
• Maintains flexibility when priorities or work assignments change.
• Shows attention to detail, accountability, and willingness to ask questions when guidance is needed.
• Contributes to a cooperative team environment and supports high-quality work outcomes.
• Takes full ownership of task quality and consistently follows through on commitments without supervision.
• Proactively identifies systemic gaps or compliance risks and drives resolution through appropriate channels.
• Demonstrates consistent reliability and regulatory expertise; serves as a reference point for peers and junior staff.
• Mentors and supports the development of Quality Inspector personnel through example, knowledge-sharing, and constructive feedback.
• Exercises sound judgment in ambiguous situations and models the professional standards expected across the quality team.
  
  
  The hiring range for this position in Camarillo, CA is $23.00 to $27.00 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills and experience among other factors. A bonus may be provided as part of the compensation package, in addition to a full range of other health and welfare benefits.