Job Summary:

This is an entry-level position viewed as a supporting resource to TS Packaging Engineer during generation of packaging records and documents required for FDA filings. Also, with appropriate level of supervision and directions from the TS Packaging Tech Writer and management, the candidate will provide daily commercial support for packaging operations and during packaging process development/optimization. TS Packaging Tech Writer understands GMP 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:

• Author/assist with preparation of new the packaging batch records and associated change controls to support the Private Label products launches and commercialization. Coordinate approval of documents in accordance with PAI procedures/practices.
• Author/review and execute (where applicable) the technical documents (i.e. protocols) for experimental, exhibit, and commercial batches as applicable to packaging process. Coordinate approval of documents in accordance with PAI procedures/practices.
• Generate documents in compliance with PAI format and procedures to allow for consistent execution of documents. Review/revise the batch records to validate for clarity, format consistency, and completeness.
• Assist TS Packaging Engineer with preparation of CMC documents to support submissions to agency (eCTD sections).
• Provide assistance to TS Packaging Engineer in the safe and compliant packaging of pharmaceutical products as related but not limited to the following activities/projects: packaging Technology Transfer, packaging process development for new products, commercial process optimization, etc.
• Provide assistance and collaborate during investigation/troubleshooting of the packaging 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.
• 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:

• Associate’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.