Supervisor, QO PR in Los Angeles, California at HYLANDS CONSUMER HEALTH INC

Summary: The QO Product Release Supervisor ensures that manufacturing records are reviewed in a timely manner. The job consists of overseeing the work of Product Release Specialists who review controlled documents for accuracy and completeness. The Product Release Supervisor is responsible for the quality, accuracy, and completeness of documentation prior to release of product and archiving of GMP documentation related to production.

Essential Duties and Responsibilities

? Establishes daily work assignments, ensures review of batch records are prioritized appropriately.

? Responsible for ensuring adequate resources/staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance to procedures.

? Responsible for communicating and/or facilitating personnel actions; including but not limited to hiring, termination, salary and performance reviews, disciplinary action, approving paid time off, overtime, etc.

? The supervisor is competent and knowledgeable in all the activities of Product Release and is responsible to ensure all personnel in area is trained and competent to applicable procedures. Leads the team by example, build relationships.

? Perform investigations, perform document changes when needed.

? Review internal production batch records for accuracy and completeness and identifying deficiencies and suggested resolutions for correction.

? Support monthly internal production metric reports for tracking, trending, and investigational purposes.

? Responsible for scheduling to ensure coverage and business continuity, tracking and follow-up of issues, develop, implement and monitoring of metrics.

? Acts as the point of contact for GDP/GMP or other quality related issues dealing with product release. Escalates any issues to supervisor/manager for resolution, as necessary.

? Apply knowledge of current Good Documentation Practices (cGDP).

? Participate in process improvement initiatives targeting for Right First Time (RFT).

? Demonstrates attention to detail, and able to recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activities.

? Ensure all deficiencies have been appropriately corrected/resolved to meet target shipment dates.

? Track review, corrections, and resolutions for trending and metrics.

? Work independently and ensure that documents tied to product release are prioritized.

? Oversee the control and distribution of status labels to support various production operations and oversees the implementation of P&L.

? Perform all responsibilities in accordance with company guidelines, Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, and regulations.

? May be required to perform other duties as assigned or as needed.

Supervisory Responsibilities: This position will have responsibility for managing a select number of direct reports.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

? High School diploma required. College degree preferred.

? 7+ years of experience in GMP regulated environment, including 5+ years in Quality organization.

? Equivalent combination of education and experience may apply.

Knowledge, Skills and Abilities

? Ability to apply an understanding of manufacturing processes and testing requirements to documents related to products.

? Able to perform data analysis extracted from databases and paper records.

? Ability to perform well under schedule requirements with minimal management support.

? Investigate discrepancies and lead problem solving teams.

? Attention to detail and ability to maintain consistency.

? Strong interpersonal communication with Hyland's personnel.

? Ability to work with members of other departments in a constructive manner.

? Superior organizational skills; able to manage more than one project at once.

? Working knowledge of PC technology (i.e. Outlook, Excel, Word, PowerPoint, Internet, etc.)

? Ability to prioritize and manage multiple time-sensitive tasks as defined and expected.

? Strong collaborative and interpersonal skills.

? Strong verbal and written communication skills.

? Ability to prepare and present written and verbal reports to Quality Management.

? Ability to lead and motivate team.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk and hear. The employee is occasionally required to stand, walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must frequently move lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

This job description is subject to change at any time.