Technical Quality Assurance Lead
Applied Industrial Technologies · Raleigh, NC · 1 mo ago
Quality AssuranceFull-time
We need to output HTML fragment with sections only if content present. Use . The content includes paragraphs with colon headings; we can treat each bullet as separate . We'll need to preserve all substantive info.
Let's list responsibilities:
- Review and engagement with PCI Customer Compliance Metrics and Scorecards
- Engagement with PCI Data Analyst and supporting review and deliverables of PCI work product
- Support on PCI Capital Project Revenue Programs in regard to quality representations, audits, and support
- Maintain and continuously improve the Quality System including the Quality Manual
- Evaluate, document, and report progress in meeting quality objectives
- Promptly address any customer complaints and assist in implementing customer solutions
- Manage the corporate document control systems
- Ensure compliance of internal programs including change and documentation control processes
- Identify areas for continuous improvement initiatives
- ISO 17025: Own the accreditation process by hosting annual audits and coordinating with internal managers accreditation scope changes
- Manage the corporate training database including system administration and end-user training
- System administration includes uploading policies and other documents, adding/removing courses and users and ensuring company-wide trainings are up-to-date
- Where applicable, provide field training to PCI associates in proper execution of technical calibration activities.
- Manage the internal audit program of the quality system
- Complete internal and external quality assessments. This will also include Field Audits
- Audit and Inspection programs within PCI training programs
- Handle client audits; both physical and paper audits
- Perform field audits of technical staff to assess proper execution of field calibrations and adherence to PCI policies and procedures as well as GxP practices
- Serve as PCI’s Safety Officer and main point of contact for all safety related matters
- Lead the Safety Committee and present valuable information back to senior leaders
- Execute safety initiatives, handle incident reports, and accurate OSHA logs
- Provide field evaluation of safety practices at PCI project sites to confirm adherence to PCI and Client safety program requirements.
We need to ensure we don't duplicate. Also note "ISO 17025 Own the accreditation process..." we can keep as bullet.
Now "Special Skills Required" list: bullet points with Ø. We'll treat as Skills section.
List:
- Self motivated individual who exhibits a professional demeanor, and enthusiasm
- Excellent organizational, analytical, problem solving and team player skills
- Strong interpersonal skills to interact confidently with clients and employees
- Possess excellent oral and written communication skills
- High attention to detail
- Effective organization and prioritization skills
- Ability to multitask
- Travel to projects in other geographical locations
- Join PCI Business Review Meetings when applicable
- Strong computer and database skills
- Experienced with Microsoft Office products
Now "Education & Experience Required": bullet? It's a sentence: "A four-year degree in Life Sciences or Quality Assurance, or other related field and six years of industry experience (or the equivalent combination of education and experience). Extensive relational database experience is also required."
We can put under Requirements or Qualifications. The instruction: Use headings for sections like Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide where to put education/experience. Likely under Requirements or Qualifications. Since they ask for Education & Experience Required, we can put under Requirements (or Qualifications). We'll choose Requirements.
Now also there is a paragraph about PCI description: "PCI is proud to serve pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions. At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT); a leading industrial distributor that offers more than 6.5 million parts to serve the needs of MRO and OEM customers in virtually every industry. Founded in 1923, Applied® provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services. Applied also offers storeroom services and inventory management solutions that provide added value to our customers. Applied Industrial Technologies is built on a philosophy that puts people first. We are an equal opportunity employer, and we are committed to a workforce in which we enforce fair treatment and provide growth opportunities for everyone. All qualified applicants will receive consideration for employment regardless of age, race, color, national origin, genetics, religion, gender, marital status, physical or mental disability, or any other characteristic protected by applicable laws, regulations, and ordinances."
We need to remove boilerplate: EEO/equal-opportunity etc. So we should drop that paragraph (the EEO statement). Also the description about PCI may be considered substantive? It's about the company; maybe we can keep as part of About the role? It's not directly about the role but could be considered company overview. The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." The company description may be considered substantive but not required for the role. However it's not boilerplate; it's about the company. We could include it under About the role as additional context. But we need to avoid EEO lines. So we keep the company description except the EEO lines.
Thus we have:
- About the role: includes initial expectations paragraph plus company description (excluding EEO). We'll combine into
for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to parse the posting. The posting includes: - Intro: "The Technical QA Lead reports to the Quality Manager or Manager of Training. This position is an exempt position. Fifty percent travel may be required. This is based on a scheduled need and requirement. Expectations: The Technical QA Lead will be actively engaged with PCI Customers and with PCI work product. The Technical QA Lead will be engaged with Field Operations and Metrology Operations. The Technical QA Lead is expected to establish, maintain and drive quality standards in accordance with corporate objectives across all business units. This individual is expected to demonstrate a strong knowledge of quality systems in the Pharmaceutical/Biotechnology industry and have a strong grasp on effectively managing multiple priorities. CCMS/CMMS (RAM), Training Database, and other Microsoft products (Excel, Word, PowerPoint) will be utilized frequently and must be used effectively and efficiently by the Technical QA Lead. The Technical QA Lead will have a strong technical background in calibration and metrology technology and practices in order to evaluate and provide corrective training on calibration execution by other associates." That's like a description; could be "About the role". We'll put that in
under
About the role
. Then "Responsibilities" heading with bullet list. Responsibilities list includes many items under subheadings: Technical Quality Deliverables for Customers, Quality Systems, Training Systems, Audits and Investigations, Safety. We need to extract each bullet as. - Responsibilities:
- ... list.
- Requirements: education/experience + maybe also mention "Extensive relational database experience is also required." plus maybe "Fifty percent travel may be required." Actually travel is mentioned earlier; could be under Requirements or maybe under Schedule? Travel is not schedule but could be under Requirements. We'll include travel under Requirements as a bullet? The instruction: Use
- for any list of duties/requirements/benefits. So we can list requirements as bullet list.
Thus Requirements bullets:
- Reports to the Quality Manager or Manager of Training.
- Exempt position.
- Fifty percent travel may be required (based on scheduled need and requirement).
- Four-year degree in Life Sciences or Quality Assurance, or other related field and six years of industry experience (or equivalent combination).
- Extensive relational database experience required.
We could also include "Strong technical background in calibration and metrology technology and practices" but that's more of a skill; maybe under Skills. But we already have Skills list includes strong computer and database skills, etc. We'll keep technical background under Skills? Actually the Skills list includes "Strong computer and database skills" and "Experienced with Microsoft Office products". The technical background in calibration and metrology is more of a qualification. Could be under Requirements as well. But we already have education/experience; we could add "Strong technical background in calibration and metrology technology and practices". However the instruction: do not create thin sections; we can add to Requirements.
We'll decide to put under Requirements bullet list.
Now Skills: we have the list from Special Skills Required.
Now Benefits, Pay, Schedule: none present, so we omit those sections.
Now we need to output only HTML fragment, no /, no markdown.
Thus:
About the role
...
Responsibilities
- ... ...
Requirements
- ... ...
Skills
- ... ...
- for any list of duties/requirements/benefits. So we can list requirements as bullet list.
Thus Requirements bullets:
- Reports to the Quality Manager or Manager of Training.
- Exempt position.
- Fifty percent travel may be required (based on scheduled need and requirement).
- Four-year degree in Life Sciences or Quality Assurance, or other related field and six years of industry experience (or equivalent combination).
- Extensive relational database experience required.
We could also include "Strong technical background in calibration and metrology technology and practices" but that's more of a skill; maybe under Skills. But we already have Skills list includes strong computer and database skills, etc. We'll keep technical background under Skills? Actually the Skills list includes "Strong computer and database skills" and "Experienced with Microsoft Office products". The technical background in calibration and metrology is more of a qualification. Could be under Requirements as well. But we already have education/experience; we could add "Strong technical background in calibration and metrology technology and practices". However the instruction: do not create thin sections; we can add to Requirements.
We'll decide to put under Requirements bullet list.
Now Skills: we have the list from Special Skills Required.
Now Benefits, Pay, Schedule: none present, so we omit those sections.
Now we need to output only HTML fragment, no /, no markdown.
Thus: