About this role
<p style="margin-bottom:11.0px"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#000000"><strong>Band Grade : </strong>5-B <br><strong>Annual Wage Range:</strong> $68,683.20 - $94,439.40 <br><strong>Other Compensation: </strong>Eligibility for the Short-Term Incentive program and other applicable bonuses <br><strong>Benefits:</strong> </span><a style="color:#0563c1;text-decoration:underline" href="https://grace.com/people-and-careers/benefits/us-employee-benefits-summary/"><span style="color:#000000">U.S. Employee Benefits Summary (grace.com)</span></a><span style="color:#000000"> </span></span></span></p> <p style="margin-bottom:11.0px"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Grace, a Standard Industries company, is a leading global supplier of catalysts, engineered materials and fine chemicals. We provide innovative products, technologies and services which our customers use to manufacture everyday products like renewable fuels, pharmaceuticals, toothpaste, cosmetics, food packaging, beer, edible oils and more. Our thousands of employees help shape a better future at our global headquarters in Columbia, MD and locations worldwide.</span></p><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>Job Description</b></H2> </div><div><p style="margin:0.0in 0.0in 8.0pt;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Grace’s South Haven site produces a portfolio of products for the specialty pharmaceutical industries, specifically Active Pharmaceutical Ingredients (API). Consisting of a cGMP kilo lab, pilot plant and custom manufacturing at commercial volumes, the site is fully equipped to develop and manufacture custom drug intermediates and APIs. South Haven is nestled on the coast of Lake Michigan with beautiful beaches and fun year-round.</span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">The Quality Assurance Specialist audits all aspects of Site operation, facilities, processes, products and documents for compliance to current Good Manufacturing Practices (cGMP), SOP and Site requirements. They document the results, resolve any nonconformance and coordinates necessary corrective actions. They coordinate validation of all aspects of Site operation, facilities and processes for compliance to cGMP, SOP, and Site requirements. They also prepare responses and Certificates of Analysis for customers and make disposition of finished product.</span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif">Schedule</p> <p style="margin:0.0in 0.0in 8.0pt;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">The Quality Assurance Specialist is on-site in South Haven, MI and reports to the Quality Assurance Supervisor.</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>Responsibilities</b></H2> </div><div><ul> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Ensure site compliance with cGMP (current Good Manufacturing Practices).</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Approve batch product deviations, assessing quality impact and proposed corrective/preventative actions.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Approve final product analytical data.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Perform product release activities, including Certificate of Analysis generation.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Management of Change – approve revisions to master batch production records, analytical test methods, cleaning procedures, SOP’s, Forms, Master Plans and Equipment Modifications.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Approve Out of Specification laboratory investigations and Deviation Reports.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Approve validation (prospective, retrospective and concurrent) of equipment, facilities, processes and methods.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Annual Product Quality Reviews – perform and document Quality portion of the review; propose corrective/preventative actions based on the review to improve product/process control and quality compliance.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Host Customer Audits and respond to audit findings.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Conduct periodic internal Quality audits of facility areas and systems, document the results, and coordinate corrective actions.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Conduct external Quality audits of contract laboratories and raw material suppliers.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Participate in FDA Audits.</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>Required Qualifications</b></H2> </div><div><ul> <li style="line-height:107%;font-size:10.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Bachelor’s degree or equivalent experience.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">5+ years of experience in a batch pharmaceutical environment.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">cGMP experience.</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>Physical Requirements and Environment</b></H2> </div><ul style="margin-top:0.0;margin-bottom:0.0"><li>Must be willing to wear PPE (Personal Protective equipment) including but not limited to hard hat, protective eyewear, steel-toed boots, hearing protection, Level A suit, full face respirator </li></ul></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 Qualifications</b></H2> </div><div><ul> <li style="line-height:107%;font-size:10.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Experience working in cross functional teams.</span></li> <li style="line-height:107%;font-size:10.0pt;font-family:Calibri, sans-serif"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Quality experience in a contract development and manufacturing organization (CDMO) environment.</span></li> </ul> <p style="line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="color:white"><strong><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">#LI-CA1</span></strong></span></p> <p style="line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="color:white"><strong><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">#WRGRACe, #Indeed</span></strong></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>Benefits</b></H2> </div><div><ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Medical, Dental, Vision Insurance</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Life Insurance and Disability</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Grace Wellness Program</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Flexible Workplace</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Retirement Plans </span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">401(k) Company Match</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Paid Vacation and Holidays</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Parental Leave</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Tuition Reimbursement</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Company Donation Match Program</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Site specific contribution to local Wellness Center</span></li> <li style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><a href="https://grace.com/people-and-careers/benefits/us-employee-benefits-summary/">https://grace.com/people-and-careers/benefits/us-employee-benefits-summary/</a></span></li> </ul></div></div></div><p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.</span></span></span></p>