About this role
<p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><u><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">WHERE YOU WILL WORK</span></u></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Without compromising our steadfast commitment to Quality, Safety and Sustainability our manufacturing and packaging facility produces in excess of 70MM units per year. This is a demonstration of our can-do attitude, collaborative spirit, focus on innovation and continuous improvement mindset. Always People First! </span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><u><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">JOB SUMMARY</span></u></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">The Quality Assurance Associate Specialist is responsible for preparing and completing the CARES act report for FDA, is responsible for BOM review and approval, Bulk and Finished Good, Responsible for Releasing Finished Goods (OTC, Non-OTC etc.) reviewing Batch records, specifications, procedures, protocols, and records for GMP compliance. </span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><u><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">WHAT YOU WILL DO</span></u></strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif"> </span></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will prepare and complete the CARESS ACT list for FDA.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will complete BOM review and approval, set up the system specifications for Finished Goods, FG, and Bulk working closely with different departments</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will be responsible for Releasing Finished Goods (OTC, Non-OTC, etc.)</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will prepare master production records for all OTC products.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will review raw material, packaging material, in-process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will perform review of Production batch records and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will aid in investigations as required.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will file and maintain batch production and control records for OTC product.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will conduct/review Annual Product Review of OTC products. Record the observations that needs follow up with AIC team.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will provide GMP Training to other departments as needed</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will research and prepare data as needed for monthly quality metrics reporting</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You will assist in any projects/tasks assigned by the Manager.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><u><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">WHO YOU ARE</span></u></strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif"> </span></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You have a bachelor’s degree (B. A.) from a four-year college or university, preferably in Engineering or Science</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You have two years’ knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You have a good understanding of 21CFR (Part210-211), ICH guidelines</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You have experience with SAP systems</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You are an expert in Excel and PowerPoint presentation.</span></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">You have good verbal and written communication skills</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><u><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">PHYISCAL REQUIREMENTS</span></u></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, if applicable. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. </span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Employees must be able to wear personal protective equipment (PPE) as required by the area of work or tasks being performed. Required PPE may include, but is not limited to, eye protection, hearing protection, safety shoes, gloves, or additional protective clothing.</span></p> <table class="MsoNormalTable" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height:11.95pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Standing</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Under 1/3</span></p> </td> </tr> <tr style="height:11.95pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Walking</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Under 1/3</span></p> </td> </tr> <tr style="height:12.6pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Sitting</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Over 2/3</span></p> </td> </tr> <tr style="height:18.4pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Use hands to finger, handle or feel</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Not Applicable</span></p> </td> </tr> <tr style="height:18.4pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Climb or balance</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Under 1/3</span></p> </td> </tr> <tr style="height:17.05pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Reach with hands and arms</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Under 1/3</span></p> </td> </tr> <tr style="height:17.05pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Stoop, Kneel, Crouch, or Crawl</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Not Applicable</span></p> </td> </tr> </tbody> </table> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <table class="MsoNormalTable" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height:11.95pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Up to 10 pounds</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Under 1/3</span></p> </td> </tr> <tr style="height:11.95pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Up to 25 pounds</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Under 1/3</span></p> </td> </tr> <tr style="height:12.6pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Up to 50 pounds</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Not Applicable</span></p> </td> </tr> <tr style="height:12.6pt"> <td style="width:220.25pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Up to 100 pounds</span></strong></p> </td> <td style="width:134.55pt;padding:0.0in 0.0in 0.0in 0.0in" valign="top"> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Not Applicable</span></p> </td> </tr> </tbody> </table> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">If this sounds like you, we want you on our team. Apply today and let's create something beautiful!</span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">Your Dreams. Our Future. </span></strong><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif"> </span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:'Aptos Display', sans-serif">#NYLaw #LI-Onsite</span></p> <p style="margin:0.0in;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p>