Jobs · Quality Assurance · North Carolina

Quality Specialist - 12-Hr Night Shift 2-2-3

Alcami Corporation · Morrisville, NC · 1 mo ago
Quality AssuranceFull-time
We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We need to parse the posting. First, there is an introductory paragraph: "At Alcami, we deliver reliable solutions..." That's about the company. Could be "About the role"? Actually "Job Summary" is there. We could treat that as "About the role" or maybe "Job Summary". The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use those headings if content exists. We need to extract content for each. Let's identify sections: - About the role / Job Summary: The paragraph after "Job Summary" describes the role: "The Quality Specialist will provide site quality support...". That's substantive. So we can have

About the role

with

containing that summary. - Responsibilities: There's a big list after "Responsibilities". It includes many bullet-like sentences. We need to put them in

  • . The list includes: Support manufacturing processes on the floor; Performs quality review and approval of complex documents, all types of data, protocols, and/or reports.; Supports quality floor audits and/or floor inspections.; Supports for client and regulatory agency audits and inspections.; Provides quality evaluation and release of support materials, products, equipment and facilities as required.; Maintains quality databases and may perform analysis and trending.; Assists with quality improvement initiatives as needed.; Develops quality SOPs or other quality documents and/or reports as needed.; Provides consultation on complex quality and compliance topics in areas of expertise.; Develops and provides training in quality and compliance topics in areas of expertise.; Provides Quality oversite for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc.; Effectively performs a variety of complex duties, on schedule, with accuracy and competency.; Maintains accurate files and records.; Ensures timely completion and compliance with cGMP and all other relevant company training requirements.; Other duties as assigned. We should keep them as list items. - Qualifications: There's a section "Qualifications" with bullet-like sentences: "Bachelor’s degree in Chemistry, Biology, or relevant field and 3+ years of related experience required, or Master’s degree in relevant field and 1+ years of related experience. Relevant GMP experience required. Experience in Environmental monitoring and critical utilities preferred for sterile operations." We can put that as
    • items. - Knowledge, Skills, And Abilities: This could be Skills section. It lists many items: Strong knowledge of regulations and SOPs..., Good written and oral communication skills., Good math skills., Good computer skills and knowledge of Microsoft Office products., Ability to be trained and to mentor., Ability to act independently., Ability to interact well with clients and regulatory agents., Ability to negotiate., Ability to interact well with employees at all levels., Ability to act as technical consultant., Uses professional concepts and company policies and SOPs to solve a variety of problems., Receives minimal instruction on day-to-day work, general instructions on new assignments. We can put these as
      • under Skills. - Travel Expectations: "Up to 5% travel required." That could be under a section maybe "Travel" but not in the list of allowed headings. The allowed headings are About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Travel is not listed, so we should not create a heading for it. However we need to preserve ALL substantive information; but we cannot create a heading not in list? The instruction says use

        for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "Use

        for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It seems they expect those headings. Probably we should only use those headings; other info like Travel Expectations could be placed under a generic

        maybe within Responsibilities? But it's not a responsibility. Could be placed under a

        after Qualifications? The instruction: "Prefer a few substantive sections over many thin ones." So we could incorporate Travel Expectations into a

        under maybe "Qualifications" or "Skills"? Not ideal. Perhaps we can create a section "Travel" but not in the list; risk of being wrong. Better to incorporate into a

        under maybe "Qualifications" as additional info? However the instruction says "Prefer a few substantive sections over many thin ones." So we could have sections: About the role, Responsibilities, Qualifications, Skills. That's four sections. Travel Expectations could be a

        under Qualifications or Skills? It's not exactly qualification but maybe under "Qualifications" as additional requirement. But it's separate. Similarly Physical Demands and Work Environment: Could be placed under maybe a

        after Skills? Not a heading. Could be included under "Skills"? Not really. We need to preserve ALL substantive information. So we need to include that info somewhere, even if not under a specific heading. We can just add

        paragraphs after the sections. Thus output:

        About the role

        ...

        then

        Responsibilities

          ...
        then

        Qualifications

          ...
        then

        Skills

          ...
        then maybe

        Travel Expectations: Up to 5% travel required.

        then

        Physical Demands and Work Environment: ...

        . Ensure we don't include boilerplate like EEO etc. The posting didn't have that. Check for any duplicated lines: We need to avoid repeating. Now craft HTML. First, About the role paragraph: Use the Job Summary text: "The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed." Make sure it's one paragraph. Responsibilities list: We'll extract each bullet. Let's list them exactly as in text: - Support manufacturing processes on the floor - Performs quality review and approval of complex documents, all types of data, protocols, and/or reports. - Supports quality floor audits and/or floor inspections. - Supports for client and regulatory agency audits and inspections. - Provides quality evaluation and release of support materials, products, equipment and facilities as required. - Maintains quality databases and may perform analysis and trending. - Assists with quality improvement initiatives as needed. - Develops quality SOPs or other quality documents and/or reports as needed. - Provides consultation on complex quality and compliance topics in areas of expertise. - Develops and provides training in quality and compliance topics in areas of expertise. - Provides Quality oversite for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc. - Effectively performs a variety of complex duties, on schedule, with accuracy and competency. - Maintains accurate files and records. - Ensures timely completion and compliance with cGMP and all other relevant company training requirements. - Other duties as assigned. Note some have capitalization inconsistencies; we keep as is. Qualifications list: - Bachelor’s degree in Chemistry, Biology, or relevant field and 3+ years of related experience required, or Master’s degree in relevant field and 1+ years of related experience. - Relevant GMP experience required. - Experience in Environmental monitoring and critical utilities preferred for sterile operations. Skills list (Knowledge, Skills, And Abilities): - Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise. - Good written and oral communication skills. - Good math skills. - Good computer skills and knowledge of Microsoft Office products. - Ability to be trained and to mentor. - Ability to act independently. - Ability to interact well with clients and regulatory agents. - Ability to negotiate. - Ability to interact well with employees at all levels. - Ability to act as technical consultant. - Uses professional concepts and company policies and SOPs to solve a variety of problems. - Receives minimal instruction on day-to-day work, general instructions on new assignments. Travel Expectations: "Up to 5% travel required." Physical Demands and Work Environment: The paragraph is long. We'll include as a

        preserving all details. Let's copy that paragraph exactly: "The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc." We'll put that in a

        . Now ensure no extra headings like "On-Site Expectations". That info: "On-Site Expectations 100% on-site position.Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am." This is schedule info. According to allowed headings, we have Schedule. So we should create a

        Schedule

        with that info. Good. Thus we have sections: About the role, Responsibilities, Qualifications, Skills, Schedule. Also maybe Benefits? Not present. Pay? Not present. Requirements? Could be combined with Qualifications? The posting has "Qualifications" section; we could treat that as Requirements? But we already have Qualifications. The instruction allows Requirements heading; but we have Qualifications content. We could map Qualifications to Requirements? But better to keep Qualifications as heading because it's present. The instruction says use

        for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use Qualifications heading. Good. Thus we will not use Requirements heading. Now output HTML fragment. Make sure to wrap each section appropriately. Let's craft:

        About the role

        The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and

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