Packaging Quality Specialist

Packaging Quality Specialist

The Packaging Quality Specialist is a critical member of the Operations team, responsible for all documentation and procedural activities associated with batch records, non-conformance investigation reports and actions that come out of the reports. This includes investigation, analysis, and writing of non-conformances and the associated reports.

Responsibilities:

• Provide documentation services to the Packaging department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.
• Support all Quality Systems for the Packaging Department, including CAPA, Change Control, NCIR tracking/trending.
• Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidance and guidelines.
• Review, update and approve Standard Operating Procedures (SOPs) and other official documents.
• Identify appropriate Corrective Action, Preventative Action (CAPA) as needed. Responsible for completion of CAPA and follow-up on effectiveness.
• Support all Continuous Improvement efforts within the department.
• Aid in support and help maintain a system for pre-campaign activities for all packaging processes.
• Develop and maintain a system for monitoring and reporting department metrics on a continual basis.
• Develop, plan, track and analyze assigned projects. Works with project sponsor(s) to define project success criteria, timelines, milestones and deliverables. Identifies project dependencies and critical paths.
• Effectively communicate and manage project expectations and success criteria to project sponsors, team members, vendors and other stakeholders in a clear and concise manner throughout the project lifecycle.
• Support Packaging Manager in reducing compliance risk by aiding in performing internal audits and developing action items to correct risks
• Perform all these functions, and others, as required by the Packaging Manager in a professional and timely manner.
• Follow and observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to area of responsibility.
• Works effectively under deadlines.
• Respects policies, procedures and regulations in force in the company.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code

Experience, Education, and Skills Required:

• Bachelor's degree in writing, math, science or engineering field
• 2+ years' experience technical writing and/or procedure development, preferably in FDA regulated environment.
• Proficient with Microsoft Office (Excel, Word, PowerPoint).
• Capable of organizing data from multiple sources, extracting key information and writing reports and summaries
• Demonstrated ability to write logically and consistently
• Assertive Influencing & Collaboration/Teaming Skills
• Strong decision making and problem-solving skills
• Excellent interpersonal written and oral communication skills
• Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
• Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
• Exceptional attention to detail and excellent organizational skills

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES

Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there's no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can't quickly verify the identity of the poster.