Serve under the quality lead within the value stream, including having the responsibility and authority to approve or reject all in-process materials bulk drug products, and/or in-process packaging, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. As part of the VSO team, drives continuous quality improvement through waste reduction, mistake-proofing; solicits and implements industry best practices; maintains awareness of current events related to compliance activities in the industry and drives implementation. Analyzes statistical data to establish quality programs and measurements to improve operations, participates in the resolution of quality issues in a timely manner; ensures value stream process and system adherence to approved procedures. Evaluates Corrective Action/Preventative Action (CAPA) effectiveness; interacts with internal/external Quality Assurance groups. Develops standard work in regards to quality acceptance criteria within the value stream. Provides batch record and other controlled document review and approval in the value stream.|
Works collaboratively within the VSO team.Work with the IPQA Leader and VSO Team planning, to develop a culture of accountability, empowerment, continuous improvement, customer focus, collaboration, celebration of good work, involvement and development of all people within the Value Stream.
Provides “on-call” coverage as needed to support value stream.
An outline of the key outcomes/deliverables that an individual will be held accountable for and the major activities/ tasks involved. Include the % of time spent on each responsibility. Total of percent should equal 100 %.
Compliance, Safety and Quality (60%)
- Maintains awareness of manufacturing activities by routine direct observation. Interacts frequently with VSO team to provide quality perspective on routine operations.
- Participates in the development of standard work practices to ensure high and consistent level of quality is maintained across shifts. Provides training to value stream personnel in standard work specifics as required.
- Monitors “Visual Factory” for quality performance. Proactively leads quality improvements.
- Mutual accountability with the VSO team to investigate, propose and initiate corrective and preventative action (CAPA) for equipment and process related issues based on root cause analysis
- Mutual Accountability to review, and propose revisions to Manufacturing batch records and SOP's as required
- Perform final QA review and provide final disposition for investigations, deviations and CAPA within the value stream.
- Performs product release/rejection function for in-process, bulk finished product materials, and in process packaged product.
- Review and approve CAPA effectiveness evaluation based on quantitative and qualitative measurements. Proactively resolves any prior CAPA deemed ineffective.
- Provide key input into investigational and CAPA tasks assigned to the value stream.
- Identify compliance risks to management with remediation proposal, and lead solution implementation.
- Write, revise, and approve SOPs as necessary.
- Lead and participate in site quality and process improvement initiatives, and project teams.
- Provide compliance support, expertise and training for the VSO.
- Lead self-check audits of the VSO and immediate support for regulatory audits.
- May provide data for value stream products for Annual Product Reviews.
- Act as QA reviewer on protocols and reports, and author as needed, with approval authority related to value stream.
- Support, participate in, and approve compliance–critical efforts including change controls and validation processes related to value stream.
- Perform batch record reviews in an efficient and timely manner.
- Review and evaluate Quality Control results for raw materials, intermediates, and finished product.
- Assure that any observations/non-conformances are properly investigated and explained. Strive to complete all releases available on shift.
- Track and evaluate any non-conformances that occur during the manufacture of cGMP material. As necessary, escalate to the Value Stream Leader and/or QA attention.
Employee Development (20%)
- Support the creation and maintenance of a “Visual Factory” to provide daily feedback on performance to objectives. Support and maintain a closed loop management process that drives continuous improvement in performance to objectives and fact based decision making.
- Drive continuous improvement and execute pro-active quality control in Value Stream processes Point out possible difficulties in, and assure compliance with the company schedule.
- Communicate with other departments within Qualitest on quality and compliance issues.
- Stay current with changes to Company Quality and Compliance policies and procedures, the Code of Federal Regulations (CFR) or FDA guidance documents so that Qualitest’s compliance policies are current.
- Participate in meetings regarding marketed product and give input on QA issues.
- As required, assist in FDA inspections regarding Qualitest marketed product or clinical supplies.
- Create training modules and assist with the training of applicable site personnel.
- Work with all Value Stream counterparts to develop a culture of accountability, empowerment, and continuous improvement, customer focus, collaboration with celebration of good work and involvement, and development of all people within the Value Stream.
- Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance. Consistently communicate, follow and enforce SOP’s and company policies and guidelines set forth in the employee handbook.
Scope of Authority
Including span of control, budget/spend authority, scope of supervisory activities, P&L responsibility, etc.
Skills: (Proficiency in manual, verbal or mental manipulation of data or things e.g. specific software skill, data manipulation skills such as modeling)
Education/experience: (The minimal acceptable level of education, work experience, and certifications necessary for employment, e.g. advanced degree on chemistry, previous work experience on drug development)
- Strong leadership, team building, and communication skills.
- Strong focus on quality and proven ability to apply a high degree of integrity.
- Customer/Stakeholder focused (understand business plans and operating environment).
- Clear problem-solving and decision-making skill.
- Minimum of a two year degree in Science, Engineering, or Pharmaceutical Studies and/or equivalent military training/certification. Work experience will be considered in lieu of degree.
- Minimum of 5 years of experience in a pharmaceutical manufacturing environment with minimum of 3 years in Quality Assurance
- Previous experience performing root cause analysis required
- CQE, ASQ or other quality certifications highly desired
Abilities: (Abilities as evidenced through activities or behaviors that are similar to those required on the job, including Endo-wide competencies, mission critical segment competencies, and functional/job specific competencies, e.g. dealing with ambiguity, action oriented, self-development, and decision quality)
- Able to communicate effectively with all levels of Qualitest personnel and regulatory inspectors.
- Ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
- Ability to perform statistical analyses, such as (but not limited to) Statistical Process Control, Cp/Cpk.
- Ability to lead with a positive and credible demeanor that engenders trust.
- Ablity to build and maintain collaborative relationships between teams, departments and business units.
- Ability to function well under pressure in a changing environment.
- Ability to organize, prioritize work in the face of shifting demands and tight deadlines.
Knowledge: (Proficiency in a body of information that can be applied directly to accomplish a task, e.g. knowledge of pain therapy, knowledge of particular drugs)
- Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, GLP, OSHA, EEOC, EPA, and DEA.
- Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
- Strong technical and quality background related to pharmaceuticals
- Working knowledge of electronic investigation systems
- 2 years ago - save job