Systems Engineer

Operations Supervisor

Quality Control Supervisor

Senior Packaging Technician

Manufacturing Operator II

Senior Operational Leadership Trainee

Associate I, Quality Operations

Validation Engineer

QC Chemist I

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>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</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>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</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>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements 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>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</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>

Responsibilities: <ul><li>Coordinates each Operator’s responsibilities during each shift.</li><li>Monitors the packaging process to ensure schedule is met within standards.</li><li>Conducts final audit of Batch Records, including MAPICS transactions, prior to going to Packaging BR Reconciler; Is qualified and capable of running all packaging equipment across the entire packaging department.</li><li>Conducts preliminary review of all daily Batch Production Record (BPR) for the line and logbook documentation to ensure detail and accuracy.</li><li>Accurately reviews BPRs steps for completeness and accuracy.</li><li>Request components, labels and inserts per the BPR.</li><li>Set up packaging machinery; accurately sets equipment programming according to BPRs and SOPs.</li><li>Conduct basic set ups, starts, operates, adjusts, troubleshoots and tears down packaging lines.</li><li>Conduct sampling: Collects samples from each batch and submits to QA for retained samples.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li><li>Conducts verification of line/equipment cleaning and documents per SOP.</li><li>Executes procedures used to clean pharmaceutical packaging equipment and facilities.</li><li>Competently conducts Master Cleans and Line Clearances.</li></ul> Requirements: <ul><li>Must be able to stand for long periods of time (8 or 12 hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Responsibilities: <ul><li>Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, potent compound, etc.&nbsp;</li><li>Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.</li><li>Executes written SOPs to ensure the purity of materials involved in the manufacturing process.</li><li>Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.</li><li>Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.</li><li>Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs.</li><li>Executes machine change-overs from batch to batch.</li><li>Requires oversight and double-checking; is typically paired with a Qualified Manufacturing Operator.</li><li>Learns sampling techniques.</li><li>Learns, understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, may participate in the debriefing session to understand the reasons why and what needs to be corrected moving forward.</li><li>Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.</li><li>Meets requirements for entries on all applicable batch production pages, completion and attachment of all dispensary and weight verification tickets.</li><li>Verifies the manufacturing process on BPR in an accurate and timely manner.</li><li>Provides status updates and operational challenges on status boards.</li></ul> Requirements: <ul><li>HS diploma or equivalent at minimum, with 0-2 years’ related experience*</li><li>Forklift certification may be required for blending and granulation.</li><li>Knowledge of cGMPs.</li><li>Has solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.&nbsp;&nbsp;</li><li>Basic math, reading, legible writing skills, and problem solving abilities.&nbsp;</li></ul>

Overview:Reporting to the General Manager, this position is a 12-month program committed to setting up future Operational Leaders (General Manager, Director, etc.) for success. The Senior Operational Leadership Trainee will complete a comprehensive training program.Upon successful completion of the 12- month training program, the Senior Operational Leadership Trainee will be prepared to be promoted into an open Leadership role.Ability to relocate is a requirement of this role.Responsibilities:Meaningfully takes part in the Senior Operational Leadership Trainee program, including travel to other units for intensive training in operations areas including Kitchen, Pick and Pack, Equipment, Storeroom, Transportation, Wash and Pack, and Human Resources. Engage in continuing development in management and Reston-based Regional learning activities.Successfully pass knowledge and competency assessments.Supports Unit operational initiatives as needed.May be directed to assist in meeting business objectives and goals related to food costs, labor costs, sanitation, quality assurance, market track goals, airline goals and objectives as well as other specific goals set.Ensures company and regional Standard Operations Procedures (SOPs) and programs are efficiently executed.Liaises with support functions such as Human Resources, Legal, Customer Service, etc. to evaluate and reduce potential risks at the unit level.Provides operating unit technical support in the areas of quality, food safety, occupational safety and health, chemical safety, waste management, waste water and storm water pollution prevention, air quality and environmental annual reporting.Maintains a fully engaged and high performing team that aligns with company values and goals.Supports customer audits and government audits to ensure compliance.Manages the operation staff on a day-to-day basis, driving to exceed set targets.Requirements:Education:Bachelor’s degree in business administration or related field required.Work Experience:5+ years of progressive management experience in a manufacturing environment.Labor relations experience required.Strong track record of innovation and making changes to the operation to further improve the work environment and unit performance.Proven experience successfully managing a team of supervisors and managers.Must be willing to relocate regionally.Technical Skills: (Certification, Licenses and Registration).Able to obtain an AOA badge and customs seal.Completes all company required training including, but not limited to, ServSafe Sanitation Manager Certification.Job Skills:Must have strong and effective leadership skills.Strong Customer Service Focus.Strong Team development and Management skills.Language / Communication Skills:Interpersonal skills and the ability to interact effectively with multiple departments and customers.Excellent written and oral communication skills.

Responsibilities:The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.Communicates to multiple departments and supervision to provide timely process and issue updates.Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.Participates in reviews and structured processes for continuous improvement.  Quality Operations:Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.Follows internal processes related to controlled substances.Performs GMP related verifications such as line clearances, cleaning, room inspection, and materialsCollects and appropriately labels packaging retain samples, and submits to the archive storageMay execute computer data entries in CME, JDE, LIMS, and/or department databases.Collects retain samples and performs sample evaluation for Annual Product Review.May backup third party product review/release.Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.Non-conforming events:Responds to and escalates events identified during production to Quality Management.Participates in investigations with the Rapid Response Team as needed.Process Improvement:Collaborates with Manufacturing and Quality partners to identify and implement improvements.Compliance:Conducts GMP walkthroughs of facilitiesLearns how to perform in-process audits to identify adherence to SOPs and BR requirements.Actively participates in training events, and maintains currency with assigned training requirements.Safety:Follows all procedures to ensure a safe and compliant work environment.Requirements:Education & Experience:High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)Ability to communicate and work with teams.Attention to detail.Strong documentation skills.Ability to read and interpret SOPs and function within the scope of procedures.

Responsibilities:The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems.They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises.They will work with quality, technical operations and production to identify and resolve issues. Adhere to all company and cGMP procedures as well as applicable safety regulations.Author change controls, SOPs and protocols.Protocols o Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.Responsible for confirming all communicated validation plans to applicable management.Provides technical assistance in the form of rationales or validation studies.Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.Troubleshoots and resolves issues as needed.Manage multiple projects with competing deadlines.Manage external resources to complete tasks outside SPI’s capabilities. Manage approvers of documents and procedures and ensure timely closure of tasks.Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee.Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.Source and procure equipment, supplies and other materials as needed.Develop and maintain cross-functional relationships. Requirements:Bachelor of Science in Engineering or Science discipline preferred.Experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries.In-depth knowledge of the pharmaceutical plant operations is an asset.Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the JobExperience authoring change controls in Trackwise or other management system.Experience authoring SOPs in MasterControl or other management system.Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions. People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently.Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes.Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.Climb ladders and work in high, precarious places up to elevations of 75 feet.Regularly exposed to work near moving mechanical parts.Exposed to wet or humid conditions.Exposed to outdoor weather conditions.Regularly exposed to high noise environments.Exposed to extremely dusty environments.Exposed to chemicals used in the manufacturing process.

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.

Skills

Industry

Location

Jobtitle

9 sops Jobs found

Systems Engineer

Operations Supervisor

Quality Control Supervisor

Senior Packaging Technician

Manufacturing Operator II

Senior Operational Leadership Trainee

Associate I, Quality Operations

Validation Engineer

QC Chemist I

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

9 sops Jobs found

Systems Engineer

Operations Supervisor

Quality Control Supervisor

Senior Packaging Technician

Manufacturing Operator II

Senior Operational Leadership Trainee

Associate I, Quality Operations

Validation Engineer

QC Chemist I

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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