Submit Your Resume

Upload File

Drop files here Or click here to upload the files

Is this not the right job for you? Create a job alert to be notified when a job that matches your criteria is posted.

The Quality Assurance Manager, Manufacturing is responsible for the overall performance of the Manufacturing Quality Assurance team to maintain GMP Compliance, enforce good documentation practices.

• Oversees, manages, coordinates, and prioritizes the daily activities related to Manufacturing QA inspectors such as sampling, inspection, equipment challenges, batch record review, issuance and control of printed material, line clearances, and retain program.
• Ensures cGMP and FDA compliance by all manufacturing employees to best practices, standards and quality.
• Partners with Technical Operations, Engineering, and Validation departments to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
• Ensures and enforces departmental compliance of all related facility SOPs and cGMPs.
• Oversee release of Manufacturing Controlled Area, passivation records, conditional releases, cleaning verifications, water releases and Notice of Rejection records.
• Responsible for QA hold, Sample request processes as well as final QA approval manufacturing work orders
• Ensure training is up to date for all team members to remain compliant.
• Review, Assess, and approve deviation reports, change controls, product complaints, product specifications, manufacturing / engineering protocols, SOPs, master batch records and forms.
• Participates in the recruitment process of interviewing and hiring.
• Conducts performance evaluations of direct reports and assists direct report supervisors with the performance evaluation process.
• Lead continuous improvement program for Quality Assurance Operations.
• Collaborate and interact internally and with customers for Root Cause Problem Solving events to address investigations and customer inquiries from a Quality perspective.
• Prepare monthly and/or quarterly quality metric presentations.
• Support client audits and regulatory inspections for QA.
• Utilize investigative techniques to determine root causes of deviations and to determine the proper corrective and preventive actions.
• Responsible for workforce management activities including, but not limited to, interviewing, hiring, training, coaching performance management, discipline, and termination recommendations.
• Develop, motivate, and lead direct reports towards achieving organizational goals.
• Lead Tier 2 Daily meetings and attend Tier 3 daily meetings as the Quality Assurance lead.
• Responsible for scheduling. Facilitates transitions between shifts and seamless handoffs. Communicates key information to peers, team members and production management.
Requirements:
  • Bachelor’s degree (BA or BS), preferably in a Chemistry, Biology, Pharmacy, Engineering, or other related technical or business administration field.
  • Minimum of 5 years of relevant experience in the pharmaceutical industry for Quality Assurance and Manufacturing environment.
  • 5 years or more of management of people, projects, functional area or a combination is preferred.
  • Excellent written and oral communication skills, sound decision-making based on experience, good supervisory skills including the ability to delegate effectively, good people-skills including the ability to coach and teach subordinates.

 

FacebookTwitter
[gravityform id="7" title="false" description="false"]
<script type="text/javascript">var gform;gform||(document.addEventListener("gform_main_scripts_loaded",function(){gform.scriptsLoaded=!0}),window.addEventListener("DOMContentLoaded",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,initializeOnLoaded:function(o){gform.domLoaded&&gform.scriptsLoaded?o():!gform.domLoaded&&gform.scriptsLoaded?window.addEventListener("DOMContentLoaded",o):document.addEventListener("gform_main_scripts_loaded",o)},hooks:{action:{},filter:{}},addAction:function(o,n,r,t){gform.addHook("action",o,n,r,t)},addFilter:function(o,n,r,t){gform.addHook("filter",o,n,r,t)},doAction:function(o){gform.doHook("action",o,arguments)},applyFilters:function(o){return gform.doHook("filter",o,arguments)},removeAction:function(o,n){gform.removeHook("action",o,n)},removeFilter:function(o,n,r){gform.removeHook("filter",o,n,r)},addHook:function(o,n,r,t,i){null==gform.hooks[o][n]&&(gform.hooks[o][n]=[]);var e=gform.hooks[o][n];null==i&&(i=n+"_"+e.length),gform.hooks[o][n].push({tag:i,callable:r,priority:t=null==t?10:t})},doHook:function(n,o,r){var t;if(r=Array.prototype.slice.call(r,1),null!=gform.hooks[n][o]&&((o=gform.hooks[n][o]).sort(function(o,n){return o.priority-n.priority}),o.forEach(function(o){"function"!=typeof(t=o.callable)&&(t=window[t]),"action"==n?t.apply(null,r):r[0]=t.apply(null,r)})),"filter"==n)return r[0]},removeHook:function(o,n,t,i){var r;null!=gform.hooks[o][n]&&(r=(r=gform.hooks[o][n]).filter(function(o,n,r){return!!(null!=i&&i!=o.tag||null!=t&&t!=o.priority)}),gform.hooks[o][n]=r)}});</script> <div class='gf_browser_unknown gform_wrapper gform_legacy_markup_wrapper' id='gform_wrapper_7' ><form method='post' enctype='multipart/form-data' id='gform_7' action='/surf_jobs/quality-assurance-qa-manager-jackson-nj-48a94342/' novalidate> <div class='gform_body gform-body'><ul id='gform_fields_7' class='gform_fields top_label form_sublabel_below description_below'><li id="field_7_7" class="gfield gfield_contains_required field_sublabel_below field_description_below gfield_visibility_visible" data-js-reload="field_7_7"><label class='gfield_label' for='input_7_7' >First name<span class="gfield_required"><span class="gfield_required gfield_required_asterisk">*</span></span></label><div class='ginput_container ginput_container_text'><input name='input_7' id='input_7_7' type='text' value='' class='large' aria-required="true" aria-invalid="false" /> </div></li><li id="field_7_8" class="gfield gfield_contains_required field_sublabel_below field_description_below gfield_visibility_visible" data-js-reload="field_7_8"><label class='gfield_label' for='input_7_8' >Last name<span class="gfield_required"><span class="gfield_required gfield_required_asterisk">*</span></span></label><div class='ginput_container ginput_container_text'><input name='input_8' id='input_7_8' type='text' value='' class='large' aria-required="true" aria-invalid="false" /> </div></li><li id="field_7_1" class="gfield gfield_contains_required field_sublabel_below field_description_below gfield_visibility_visible" data-js-reload="field_7_1"><label class='gfield_label' for='input_7_1' >Email<span class="gfield_required"><span class="gfield_required gfield_required_asterisk">*</span></span></label><div class='ginput_container ginput_container_email'> <input name='input_1' id='input_7_1' type='email' value='' class='medium' aria-required="true" aria-invalid="false" /> </div></li><li id="field_7_10" class="gfield gfield--width-full gfield_contains_required field_sublabel_below field_description_below gfield_visibility_visible" data-js-reload="field_7_10"><label class='gfield_label' for='input_7_10' >Phone number<span class="gfield_required"><span class="gfield_required gfield_required_asterisk">*</span></span></label><div class='ginput_container ginput_container_phone'><input name='input_10' id='input_7_10' type='tel' value='' class='large' aria-required="true" aria-invalid="false" /></div></li><li id="field_7_11" class="gfield gfield--width-full gfield_contains_required field_sublabel_below field_description_below gfield_visibility_visible" data-js-reload="field_7_11"><label class='gfield_label' for='input_7_11' >Which industry do you work in?<span class="gfield_required"><span class="gfield_required gfield_required_asterisk">*</span></span></label><div class='ginput_container ginput_container_text'><input name='input_11' id='input_7_11' type='text' value='' class='large' aria-required="true" aria-invalid="false" /> </div></li><li id="field_7_12" class="gfield gfield--width-full gfield_contains_required field_sublabel_below field_description_below gfield_visibility_visible" data-js-reload="field_7_12"><label class='gfield_label' for='input_7_12' >Upload my resume<span class="gfield_required"><span class="gfield_required gfield_required_asterisk">*</span></span></label><div class='ginput_container ginput_container_fileupload'><input type='hidden' name='MAX_FILE_SIZE' value='838860800' /><input name='input_12' id='input_7_12' type='file' class='large' aria-describedby="gfield_upload_rules_7_12" onchange='javascript:gformValidateFileSize( this, 838860800 );' /><span class='gform_fileupload_rules' id='gfield_upload_rules_7_12'>Max. file size: 800 MB.</span><div class='validation_message validation_message--hidden-on-empty' id='live_validation_message_7_12'></div></div></li><li id="field_7_13" class="gfield gform_validation_container field_sublabel_below field_description_below gfield_visibility_visible" data-js-reload="field_7_13"><label class='gfield_label' for='input_7_13' >Email</label><div class='ginput_container'><input name='input_13' id='input_7_13' type='text' value='' autocomplete='new-password'/></div><div class='gfield_description' id='gfield_description_7_13'>This field is for validation purposes and should be left unchanged.</div></li></ul></div> <div class='gform_footer top_label'> <input type="submit" id="gform_submit_button_7" class="gform_button button om-trigger-conversion" value="Submit" onclick='if(window["gf_submitting_7"]){return false;} if( !jQuery("#gform_7")[0].checkValidity || jQuery("#gform_7")[0].checkValidity()){window["gf_submitting_7"]=true;} ' onkeypress='if( event.keyCode == 13 ){ if(window["gf_submitting_7"]){return false;} if( !jQuery("#gform_7")[0].checkValidity || jQuery("#gform_7")[0].checkValidity()){window["gf_submitting_7"]=true;} jQuery("#gform_7").trigger("submit",[true]); }'> <input type='hidden' class='gform_hidden' name='is_submit_7' value='1' /> <input type='hidden' class='gform_hidden' name='gform_submit' value='7' /> <input type='hidden' class='gform_hidden' name='gform_unique_id' value='' /> <input type='hidden' class='gform_hidden' name='state_7' value='WyJbXSIsIjYzZTkzNzhkY2Y1YmUzYzkyOTg0MmI4YmYyZWI5OGVkIl0=' /> <input type='hidden' class='gform_hidden' name='gform_target_page_number_7' id='gform_target_page_number_7' value='0' /> <input type='hidden' class='gform_hidden' name='gform_source_page_number_7' id='gform_source_page_number_7' value='1' /> <input type='hidden' name='gform_field_values' value='' /> </div> </form> </div>
["gf_submitting_3"]
["gf_submitting_3"]
[true]
[true]
[3, 1]
[3, 1]
[2, 1]
[2, 1]
["gf_submitting_3"]
["gf_submitting_3"]
[true]
[true]
[3, 1]
[3, 1]
["gf_submitting_3"]
["gf_submitting_3"]
[true]
[true]
[3, 1]
[3, 1]
["gf_submitting_3"]
["gf_submitting_3"]
[true]
[true]
[3, 1]
[3, 1]
["gf_submitting_3"]
["gf_submitting_3"]
[true]
[true]
[3, 1]
[3, 1]