PAI Holdings LLC is hiring: Packaging Technical Writer in Greenville

Job Summary:

This position supports all Operations areas of the organization including but not limited to Packaging, Manufacturing, Engineering and Maintanance groups during generation or revision of packaging / Manufacturing documents. Also, the candidate will provide daily support for packaging operations and during packaging process or documentation optimization. Packaging Tech Writer understands cGMP requirements and basic theories and concepts for liquid dosage manufacturing.

Supervisory Responsibilities:

No supervisory responsibilities. Individual contributor, not responsible for the work of others.

Duties/Responsibilities:

• Write, edit, review cGMP documents, Standard Operating Procedures (SOP’s), Work Instructions (WI’s), Protocols, Manufacturing and Packaging Records, and master batch records
• Edit documents written by others to improve communication efficiency
• Comply with format and practices to allow for consistent execution of documents
• Interact with department personnel to establish priorities for documents
• Assist with completion of operations quality deviations and investigations as needed
• Complete CAPAs generated from Deviation Reports
• Assist with compilation of weekly/monthly operations metrics; OEE, yield, scrap, labor trends, etc.
• Lead efforts to identify and implement improvements on documents / logbooks that aim to simplify and streamline the documentation and audit processes.
• Perform other job-related duties as assigned to meet departmental and company objective.

Required Skills/Abilities:

• Competent in English with strong written and verbal communication skills. Strong initiative and integrity as well as technical writing skills with attention to detail. Strong presentation and analytical skills.
• Ability to collaborate with members of the organization at all levels and from different functional groups
• Able to work in a team environment as well as independently.
• Able to prioritize, organize, give appropriate attention to detail, and work effectively with minimal supervision including strong follow-up skills, and the ability to provide timely closure of assigned tasks is required.
• Strong customer orientation. Able to develop relationships and effectively collaborate within and outside the functional area on routine matters.
• Preferred knowledge of and experience in pharmaceutical packaging systems (bottle, cup, unit-dose fill/seal, induction seal, etc.)

Education and Experience:

• Bachelor's degree in Science or Engineering is preferred or an advanced degree in lieu of experience.
• 0-2 years of experience within the Pharmaceutical industry or appropriate degree in-lieu of experience.
• Experience as a Technical Writer in a cGMP regulated environment writing documentation in support of audit and compliance activities is highly desirable.
• Experience in liquid-dosage manufacturing is preferred.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled

Benefits:

Excellent benefits including On-Site Wellness Clinic, health, dental, vision, STD/LTD, and life insurance, HSA with employer contribution, 401(k) and Roth 401k, Employee Assistance Program (EAP), Allstate Plans: Accident – Cancer – Critical Illness, paid holidays and PTO. Excellent compensation package pending experience and qualifications.

About PAI:

PAI Pharma has been at the forefront of producing better-targeted suspensions, oral solutions, elixirs, syrups, and liquids for nearly 50 years. PAI Pharma's mission is to participate in the creation of healthier lives by exceeding the expectations of those we serve with innovative treatments.

PAI Pharma has an extensive product portfolio including over the counter and prescription solutions, elixirs, syrups, and semi-solids. To meet the unique needs of retail chains and independent pharmacies, hospitals, long-term care facilities and government agencies, PAI Pharma offers standard bottle packaging and ready-to-dispense unit-dose packaging.

PAI Pharma also develops original formulations and new drug delivery systems governed by a strict quality validation process. We strive to offer more user-friendly formulations in more enticing flavors. Our core strength is in pharmaceutical ingredients, dosage form, and analytical chemistry of generic medicines and wellness products.

This job description is not a contract, and the duties/expectations and requirements may change.