About this role
<p> </p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? </span></p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. </span></p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. </span></p> <p> </p> <p> </p><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H4 style="font-size:1.0em;margin:0.0px"><b>Job Summary</b></H4> </div><div><p><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">This role is essential in ensuring customer specifications and timelines are met and is accountable for in-process quality control services and support. The Quality Specialist role will be responsible for materials acceptance activities, provide additional quality inspection, quality control testing, sampling inspection and documentation control activities within the Quality team. Adhering to Good Documentation Process (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records. The Quality Specialist will handle projects and tasks in support of product development and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting company and regulatory requirements.</span></p> <p> </p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><strong>Shift:</strong> Nights (12-hr on 2, 2, 3 rotation)</span></p> <p> </p> <p><span style="color:white;font-family:arial, helvetica, sans-serif;font-size:12.0pt">#LI-MQ1</span></p> <p><span style="color:white;font-family:arial, helvetica, sans-serif;font-size:12.0pt">#Onsite</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Essential Duties and Responsibilities</b></H2> </div><div><p><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Manage and maintain traceable, accountable, password protected, documentation system in compliance with Corporate guidelines.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Inspects in-process production by confirming specifications, conducting Visual, Dimensional and Functional tests, and communicating required adjustments to required personnel. May lead the process for raw materials acceptance activities including issuance of Certificate of Compliance.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Support batch release by completing batch card review and provide quality document control oversight on documentation and reports.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Collaborate with teams on the development of product development DHF documents, specifically in regard to facilitating document control activities.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Contribute to and support the development of product development QMS procedures and work instructions.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Calibrates all equipment gauges, measuring devices, weighing devices and hand-held gauging devices.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Identify, define, monitor, track, and report on documentation metrics (e.g., documentation release rates, documentation rejection rates, etc.).</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Responsible for identification, front line management and appropriate escalation of major and critical incidents.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Generate associated OOS/Deviation/Non-Conformances.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Leading the process of the approval of all graphic and label related raw material.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Establish routine communication strategies for project tracking and prioritization.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Drive continuous quality improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Responsible for conducting Production floor GEMBA walks.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Compliance to all Environmental, Health and Safety regulations.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">• Compliance to all company policies, procedures, and corporate policies</span>.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Education</b></H2> </div><div><ul> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">High school diploma or GED required.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Bachelor's degree, vocational or technical training or degree with emphasis in Quality Control preferred.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Work Experience</b></H2> </div><div><ul> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">No minimum required.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">2+ years of experience in regulated Quality Assurance/Quality Control preferred.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">2+ years of experience in medical devices or pharmaceuticals industry preferred.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Additional Requirements</b></H2> </div><div><ul> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Must maintain the ability to work well with others in a variety of situations.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Effectively communicate and interface with various levels internally and with customers.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Preferred Knowledge, Skills and Abilities</b></H2> </div><div><ul> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Ability to work independently, multi-task and thrive in a fast-paced environment.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Experience with managing Document Control activities within a regulated industry.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Excellent written and verbal communication skills.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Familiarity with Master Control, SAP/ERP system and SharePoint.</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:12.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">Must have effective problem solving and interpersonal skills.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Travel Requirements</b></H2> </div><div><div>None: No travel required</div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Physical Requirements</b></H2> </div><div><div>Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.</div></div></div></div><p> </p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:12.0pt">West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening. </span></p>