Sr. EHS Site Manager

EHS Manager

Utilities Account Manager

Site Investigation Lead, Quality Assurance

Quality Control Supervisor

Lead Quality Specialist - Investigator

Responsibilities:&nbsp; <ul><li>Lead and manage the Wilsonville site’s EHS&amp;S team and programs.</li><li>Ensure compliance with local, state, and federal environmental and safety regulations including OSHA, EPA (CAA, CWA, RCRA, TSCA, SARA), and our client internal standards.</li><li>Develop, implement, and monitor EHS performance metrics and reports for internal and external stakeholders.</li><li>Drive continuous improvement in areas such as Behavior-Based Safety (BBS), ergonomics, hazardous waste, machine safety, and energy reduction.</li><li>Maintain and manage environmental permits, licenses, and records.</li><li>Oversee incident investigation and corrective action programs.</li><li>Act as the primary contact for regulatory agencies and third-party auditors.</li><li>Manage the EHS&amp;S budget and related capital projects.</li><li>Support ISO 14001 environmental management system implementation and certification.</li><li>Promote employee engagement and awareness across the site through training, communications, and EHS culture-building activities.</li><li>Coordinate sustainability initiatives targeting Scope 1, 2, and 3 emissions, water usage, and waste reduction.</li><li>Engage with site leadership in operations, maintenance, quality, and procurement to ensure integrated EHS compliance and strategy.</li><li>Stay abreast of regulatory changes and adapt internal policies accordingly.</li></ul> Requirements: Qualifications&nbsp; <ul><li>Bachelor’s degree in Environmental, Health &amp; Safety or related field (required).</li><li>10+ years of EHS experience in a manufacturing environment.</li><li>Experience in medical device manufacturing or similarly regulated industry preferred.</li><li>CSP (Certified Safety Professional) preferred.</li><li>Experience implementing and managing EHS systems and ISO 14001 certification.&nbsp;</li></ul>

Responsibilities: <ul><li>Lead all EHS&amp;S initiatives at the Medway site.</li><li>Build and maintain a strong safety culture across departments.</li><li>Ensure compliance with federal, state, and local regulations including OSHA, EPA (CAA, CWA, RCRA, TSCA, SARA), and internal our client standard.</li><li>Develop and implement EHS programs, training, and internal audits.</li><li>Manage environmental permits, licenses, and waste disposal practices.</li><li>Coordinate emergency preparedness and hazardous material controls.</li><li>Lead incident investigations and root cause analysis.</li><li>Maintain ISO 14001 certification and drive continuous improvement.</li><li>Prepare EHS reports and metrics for internal and external stakeholders.</li><li>Represent the site during audits by customers and regulatory agencies.</li><li>Oversee EHS budget and manage third-party consultants or vendors as needed.</li></ul> Requirements: Qualifications &amp; Experience&nbsp; <ul><li>Bachelor’s degree in Environmental, Health &amp; Safety or related field (required).</li><li>7+ years of EHS experience in a manufacturing environment.</li><li>Experience in medical devices or other highly regulated industries preferred.</li><li>CSP (Certified Safety Professional) certification preferred.</li><li>Experience with ISO 14001 implementation.</li><li>In-depth knowledge of hazardous waste, air/water compliance, chemical management, and emergency response protocols.</li></ul>

Key Responsibilities: <ul><li>Develop and maintain strong relationships with utility stakeholders to understand their business objectives and align our client solutions accordingly.</li><li>Collaborate with decision-makers to expand utility incentives and integrate new models into our client pilots and long-term solutions.</li><li>Act as a strategic liaison among utilities, partners, and internal teams to ensure alignment on timelines, deliverables, and goals.</li><li>Advocate for energy policies and incentives supporting our client Energy’s portfolio.</li><li>Develop scalable engagement strategies for both pre-commercial and full commercial solution launches.</li><li>Identify and develop opportunities for joint microgrid and energy management initiatives.</li><li>Support our client internal channels and partners to drive portfolio adoption within assigned utility territories.</li><li>Manage revenue forecasting, account growth, and portfolio adoption.</li></ul> Level of Responsibility <ul><li>Influences strategic business decisions at the executive level.</li><li>Tackles complex issues requiring in-depth analysis and investigation.</li><li>Engages regularly with senior leadership and external stakeholders on high-impact matters</li></ul> Required Qualifications <ul><li>Bachelor’s degree.</li><li>Minimum of 6 years in strategic account management.</li><li>At least 3 years of experience managing strategic initiatives with utilities or large enterprise partners.</li><li>Willingness and ability to travel up to 50% within the U.S.</li></ul> Requirements: Preferred Qualifications <ul><li>Bachelor’s degree in business, Engineering, or related field; advanced degree preferred.</li><li>Experience with strategic account management in the utilities or energy sector.</li><li>Knowledge of demand response programs, VPPs, and distributed energy resources (DER).</li><li>Familiarity with HVAC systems and battery technologies.</li><li>Demonstrated ability to execute consultative sales strategies and grow value for utility customers.</li><li>Direct experience in sales or account management with utilities.</li><li>Highly organized and capable of managing multiple priorities in ambiguous environments.</li><li>Strong negotiation and contract review skills.</li><li>Proven leadership and cross-functional collaboration capabilities.</li><li>Excellent written and verbal communication skills.</li><li>Program management experience and a strong record of leadership and influence are a plus.</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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6 geotechnical investigation Jobs found

Sr. EHS Site Manager

EHS Manager

Utilities Account Manager

Site Investigation Lead, Quality Assurance

Quality Control Supervisor

Lead Quality Specialist - Investigator

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6 geotechnical investigation Jobs found

Sr. EHS Site Manager

EHS Manager

Utilities Account Manager

Site Investigation Lead, Quality Assurance

Quality Control Supervisor

Lead Quality Specialist - Investigator

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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