Senior Technical Writer chez PL Developments

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.

SUMMARY:

The Senior Technical Writer will focus on quality management in a cGMP environment, specifically within the pharmaceutical or food industries. The position involves creating and revising key technical documents, such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and product specifications to meet regulatory requirements. The individual will also support quality by conducting investigations, and performing root cause analysis. This role requires a solid background in technical writing, laboratory practices, regulatory requirements, and quality management systems. It also involves hands-on approach in a GMP production environment and collaboration with cross-functional teams.

Work Schedule: Monday - Friday 8am-5pm

JOB QUALIFICATIONS:

• Minimum of a bachelor’s degree in engineering or science related field (or equivalent work experience)
• Minimum 5 to 7 years of technical writing in a cGMP environment authoring technical reports, Deviations, Standard Operating Procedures, Work Instructions, Product Specifications, R&D reports, etc..
• Strong understanding of GMP manufacturing and liquid filling, secondary packaging, QA requirements, and QC analytical principles, testing, and instrumentation, including FDA, USP, and cGMP regulations for pharmaceutical and/or food industry
• Experience referencing and applying compendia for pharmaceutical and food industry such as USP/NF, FCC
• Demonstrated ability to apply mathematical skills in a work setting including calculations, conversions, and accurate use of numerical data.
• Solid experience with root cause analysis and CAPA determination
• Experience with Quality Management System software utilizing document management and change control systems
• Technical knowledge of USP Purified Water generation systems is a plus
• Proficient in Microsoft Word and Excel, including calculations, PowerPoint and Outlook
• Expertise in English grammar and content editing; attention to detail
• Efficient with time management and ability to handle multiple tasks with on time delivery
• Strong oral and written communication skills
• Ability to travel to other PLD sites and/or to attend off-site training, as needed

POSITION RESPONSIBILITIES:

• Create and/or revise quality documents such as Master Batch Records, Compounding Records, Standard Operating Procedures (SOP), Work Instructions (WI), Preventive Maintenance (PM), and other documentation for new/improved PLD products or processes at the OGR site.
• Track progress of project assignments, attend required project meetings, and escalate issues or delays to ensure all quality standards are implemented and start up deadlines are met.
• Support QA, Engineering, Validation, and Operations by conducting research on various technical topics or equipment related to the process or testing requirements. Contact vendors as needed.
• Understand regulations, customer requirements, and/or user requirements related to new product or process, as required.
• Review product formulation calculations against label claim in collaboration with R&D. Update Bill of Material items (BOM) for product bulk formulations in QMS based on approved Quantitative Formula (QF). Create compounding manufacturing batch records to production scale.
• Create or edit packaging batch records for new products or processes as applicable.
• Assist Operations, Validation, and Quality with deviation investigations, as needed, related to the new start up products or processes.
• Conduct work with accurate understanding of site compounding processes, properties and purpose of raw materials, cleaning/sanitization and CIP processes, and environmental monitoring.
• Provide technical support for USP Purified Water System as needed
• Assist QC in creating and/or revising raw material and finished product specification documents to meet compendial specification, and/or regulatory or customer requirements.
• Route SOPs, Work Instructions, batch record documents, specifications, and other technical documents in a timely manner for approval in the Quality Management System.
• Adhere to all company SOPs, GMPs, and quality policies in the creation, revision, or training of documents.
• Create and/or review risk assessments to support regulatory requirements for PLD products and ingredients.
• Train on HACCP, PCQI and other food safety related principles to support projects in Food manufacturing and filling
• Other duties as assigned by manager in support of QA or Operations projects or needs

PHYSICAL REQUIREMENTS:

• Position could be exposed to various work environments such as office, production areas, laboratory, warehouse, outside, etc.
• Talking, listening, sitting, standing, walking, and climbing stairs are required frequently.
• Can be required to stand for long periods of time in a laboratory environment and/or working at a desk on a computer for long periods of time.
• As needed, able to lift and carry light loads (NMT 20 lbs.).
• Position could be exposed to hazardous chemicals and other chemical raw materials or ingredients.
• Handling and manipulating objects using hands and arms may be required.
• Must be able to wear proper gowning and PPE in laboratory and production areas, as required, to meet GMP and/or OSHA requirements. Must be able to follow all safety requirements as applicable to the area and task.

BENEFITS:
PLD is a proud employer offering many corporate benefits, including:

⦁ Medical and Dental Benefits

⦁ Vision

⦁ 401K with employer match

⦁ Group Life Insurance

⦁ Flex Spending Accounts

⦁ Paid Time Off and Paid Holidays

⦁ Tuition Assistance

⦁ Corporate Discount Program

⦁ Opportunities to Flourish Within the Company

PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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