Site Investigation Lead, Quality Assurance

Systems Engineer

Quality Control Supervisor

Operation Supervisor

QC Chemist I

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>

Responsibilities: <ul><li>Respond, manage, and escalate (as needed) technical support requests via the ticketing system, telephone calls, and emails either directly or using remote support tools.</li><li>Responsible for supporting Business user end point devices (Laptops/desktops/Smart phones/Tablets /video conferencing services) either directly or using remote support tools on as-needed basis.</li><li>Ensure compliance of regulatory requirements including cGMP standards and site-specific SOPs when completing assigned functional activities.</li><li>Manage and maintain analytical laboratory and computerized manufacturing control systems in a GMP environment according to established regulatory requirements.</li><li>Perform L1 tasks on Server, Network and Telecom Infrastructure in USA &amp; Canada as needed.</li><li>Assist Core teams in performing L1 troubleshooting tasks on Security tools, technologies &amp; platforms like Crowdstrike, Zscaler, Zero Trust, Privileged access management.</li><li>Maintain inventories of endpoint devices, GMP assets and applications.</li><li>Ensure 100% compliance with the GMP Policies and Procedures.</li></ul> Operations: <ul><li>Handle day to day end user support tickets. Provides IT support to VIP users.</li><li>Work with central IT teams to resolve issues reported via helpdesk system.</li><li>Owns end-to-end responsibility for resolving issues in a timely manner.</li><li>Provides updates on Infrastructure health and corrective/preventive actions.</li><li>Maintains an up-to-date inventory of endpoint devices, servers, GMP assets, OT devices and Network devices.</li><li>Flexible to work in a multi-shift operation environment.&nbsp;</li><li>Can be onsite on need basis to assist during any crisis in off-business hours.</li><li>Ensure site IT SOPs are updated and supports site QA and CSV on GMP tasks.</li></ul> Requirements: Education Qualifications:&nbsp; <ul><li>Bachelor’s degree (IT) or similar Desired Certifications.</li><li>Certifications (preferred) – Current JNCIE-ENT, JNCIE, or CCIE certification/ CCNP, CEH, CISSP, MCSA etc.</li></ul> Experience Required: <ul><li>3 – 5 years’ experience working in a GMP compliant pharmaceutical laboratory/manufacturing environment.</li><li>Working Knowledge of Cisco, Juniper, Aruba Technologies &amp; Architectures (examples- Cloud &amp; Cloud Security, Networking- Network Segmentation, Patching, Next-Gen AV, Avaya VOIP, Teams based Conferencing systems)</li><li>Experience managing and maintaining servers, LAN, IP Phone and WAN systems; Switches/ Routers/ Access Points, VPNs; Knowledge of IT-OT Network Segregation.</li><li>Working knowledge of networking concepts such as Routing, Switching, VLANs, VPNs, DHCP and DNS.</li><li>Hands-on experience with Windows 10/11, Microsoft Office tools, common business applications, digital signing applications, Adobe software, Apple devices and L1 knowledge of Windows Server operating systems, Virtualization Hypervisors like VMWare and Wireless Networking devices like Aruba/HPE.</li><li>Has good knowledge for troubleshooting Microsoft 365 and Microsoft Teams rooms (conferencing systems)</li><li>Oversee and ensure timely repair/replacement of faulty hardware including endpoint devices, network hardware and appliances.</li><li>Well versed on GMP Infrastructure and Applications used in Manufacturing and Laboratories.</li><li>Well versed with GMP Procedures</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>

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</li></ul>

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.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.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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5 cgmp Jobs found

Site Investigation Lead, Quality Assurance

Systems Engineer

Quality Control Supervisor

Operation Supervisor

QC Chemist I

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Site Investigation Lead, Quality Assurance

Systems Engineer

Quality Control Supervisor

Operation Supervisor

QC Chemist I

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