POSITION SUMMARY:
The QA Specialist is responsible for independently conducting thorough review of batch production records and supporting documentation to ensure products meet FDA, EMA, and internal QMS requirements prior to disposition and release. Applies working knowledge of cGMP regulations, SOPs, and quality systems to identify discrepancies, support deviation management, and contribute to continuous improvement initiatives within a CDMO environment.
PRINCIPAL DUTIES:
Batch Record Review
Independently review executed batch records and associated documents (testing reports, equipment logs, deviations, cleaning records) for completeness, accuracy, clarity, and compliance with SOPs and regulatory requirements.Review draft batch records for completeness, accuracy, and clarity prior to manufacturing.Verify critical process parameters, in-process controls, and documentation entries against approved master batch records and specifications.Identify and document discrepancies or missing information; escalate appropriately to senior specialist or supervisor.Review deviations impacting batch quality and ensure proper documentation and closure prior to batch release.Verify final completeness of batch record information prior to releasing the batch record.Perform creation and scanning of batch record package binders (Manufacturing Batch Records and Labeling and Packaging Batch Records).Follow cGMP/cGDP, FDA compliance, and ALCOA+ data integrity principles consistently.Deviation & CAPA Support
Review and support the documentation and closure of deviations impacting batch quality.Assist in CAPA development and implementation related to recurring batch record errors.Report nonconformances and follow escalation pathways per SOPs.Identify trends and recurring errors; communicate findings to supervisor.Documentation & Compliance
Maintain and control quality records in accordance with document control procedures.Support documentation review activities (e.g., batch record documentation, environmental monitoring records).Adhere to regulatory standards (FDA, EMA, ICH, ISO, GMP) in all review activities.Participate in internal audits and support external inspections as needed.Continuous Improvement
Identify inefficiencies in batch record review workflows and communicate observations to QA leadership.Recommend process improvements to enhance speed, accuracy, and compliance.Assist in the revision of SOPs and work instructions related to batch record review.May perform other duties as assigned.JOB REQUIREMENTS:
Working knowledge of cGMP (US, EU, ICH) regulations and manufacturing processes (Formulation, Filling, Packaging).Demonstrated proficiency in batch record review and product release activities.Ability to identify compliance gaps and document findings clearly and concisely.Familiarity with quality systems including Deviation, CAPA, Change Control, and Document Control.Strong attention to detail and documentation skills consistent with ALCOA+ principles.Good verbal, written, and organizational communication skills.Ability to work independently with minimal supervision while adhering to timelines.Team player with a continuous-improvement mindset.Must demonstrate integrity, accountability, sound judgment, and a commitment to quality.Proficient in electronic quality management systems (eQMS) and Microsoft Office.EDUCATION and/or EXPERIENCE:
Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field preferred; or Associate's degree (AS) with relevant experience.2–4 years of experience in batch record review and/or product release in a GMP-regulated environment.Experience in QA within a regulated industry (pharma, biotech, medical devices, CDMO).Demonstrated understanding of FDA and/or EMA regulatory requirements for batch record review and product release.Physical Requirements
Ability to lift and carry boxes or binders weighing up to 25 lbs.Ability to stand, walk, and move between departments or storage areas as part of regular duties. Read LessPOSITION SUMMARY:
Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques, and procedures. Able to assist in the preparation of reports, records, etc., for assigned tasks. Other responsibilities include monitoring, troubleshooting, maintaining, and validation of equipment required for related manufacturing operations including support systems, as applicable.
PRINCIPAL DUTIES:
Familiar with related GMP procedures and requirements, as directly related to the position.Ensure that appropriate procedures and processes are utilized without unauthorized modificationsReview all specifications, criteria, etc., and ensure all specified materials, equipment, and processes meet the required guidelines and/or industry standards. Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.Perform sanitization of clean rooms, sterilization and depyrogenation of manufacturing equipment.Perform and or assist in validation of protocols for specific projects in compliance with IQ/OQ/PQ requirements and industry guidelines.Assist in developing SOPs for all manufacturing related activities as required for a GMP compliant Fill/Finish operation.Perform all duties and manufacturing activities according to the applicable guidelines, i.e., FDA, GMP, ICH, etc. Ability to problem solve and assist in technical decision-making commensurate with level of experiencPerform various manufacturing duties and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOPs.Familiarity with computers and software programs utilized for the generation of data and associated reports as related to manufacturing operations.Available to work other shifts when necessary. Performs other related duties and responsibilities as assigned.QUALIFICATIONS AND EXPERIENCE:
Education: A Minimum of high school diploma or an associate degree in a related field.Skills: Key skills include proficiency in operating and maintaining manufacturing machinery, understanding of pharmaceutical production processes, attention to detail, problem solving abilities, and knowledge of Good Manufacturing Practices (GMP).Experience: A minimum of 2 years of relevant experience Read LessPOSITION SUMMARY:
The (Temp)QC Chemistry Laboratory Technician is responsible for supporting operations in the quality control analytical laboratory, including basic laboratory testing, solution preparation, laboratory housekeeping, waste disposal, and lab inventory management.
RESPONSIBILITIES:
Perform routine testing for WFI samples, including appearance, TOC, conductivity, and endotoxins.Assist QC Chemists with reagents, buffers, standards, and sample preparation and routine testing activities, as assigned. Perform basic laboratory testing (i.e., pH, color/clarity, osmolality, wet chemistry) for finished product release, stability studies, and raw materials, as assigned.Dispose of laboratory waste in accordance with safety and environmental procedures. Perform routine laboratory housekeeping, including glassware cleaning and lab cleanup/ organization activities.Support management of laboratory inventory: order, receive, label, and store chemicals and supplies, and ensure laboratory materials are within expiration and retest dates. Follow current Good Manufacturing Practices (cGMP), SOPs, and safety requirements.QUALIFICATIONS AND EXPERIENCE:
Associate degree in Chemistry, Biochemistry, or a related field. Bachelor's degree is a plus. 0–2 years of chemistry laboratory experience. Internship, academic laboratory, or GMP laboratory experience is beneficial. Experience in a GMP environment is preferred.Basic understanding of laboratory practices and scientific principles. Ability to follow written procedures and instructions. Strong attention to detail and organizational skills. Ability to maintain accurate records and documentation. Proficiency with Microsoft Office and laboratory software for data collection and analysis. Effective communication skills, both written and verbal, for interaction with staff and vendors.Ability to work independently and as part of a team in a fast-paced GMP environment.POSITION SUMMARY:
The Technical Product Lead will drive product and project leadership for Pyramid Labs. This role supports programs from initial facility fit assessment and technology transfer through client interaction, process improvements, validation, and commercial manufacturing. The Technical Product Lead will be part of the MS&T (Manufacturing Science & Technology) group, leading client interactions, internal project management, and technical and business process improvements.
RESPONSIBILITIES
New Product Introduction:
Lead and contribute to proposal writing and review.Conduct facility fit assessments for new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations.Oversee technology transfer activities between development and manufacturing. Translate process development reports into manufacturing batch records and SOPs.Provide hands-on manufacturing process training as part of technology transfer.Project Management:
Develop and lead process improvement projects. Implement systems for improved GMP planning, scheduling, and execution.Oversee the lifecycle management of clinical and commercial programs. Develop and manage comprehensive project plans, sharing key deliverables with internal and external stakeholders.Serve as a primary client liaison, ensuring high-quality contract manufacturing services. Act as a technical interface between internal teams and client partners.Quality & Compliance:
Support root cause investigations and CAPA (Corrective and Preventive Actions) implementation.Author and manage change control for internal and client-related projects.Drive operational excellence in collaboration with Manufacturing by identifying and implementing process improvements.QUALIFICATIONS AND EXPERIENCE:
Bachelor’s Degree in Sciences or Engineering or equivalent experience.5 years of experience supporting biotech or pharmaceutical manufacturing operations. 5 years of experience in project management within a biotech, pharmaceutical, or CMO setting.Experience with aseptic operations and drug product manufacturing strongly preferred.Strong understanding of GMP regulations and compliance within manufacturing facilities.Ability to analyze and improve manufacturing process data.Excellent written and verbal communication skills (technical writing ability required).Ability to work cross-functionally within internal and external teams to drive project success.Self-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment. Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfaction. Read LessPosition Summary:
The role of Project Manager is instrumental in the execution of client programs. This role requires an efficient and organized individual who can successfully manage a large portfolio of projects. Utilizing the guidelines in the Pyramid Pharma Services Project Management Handbook along with standard project management tools and practices, the Project Manager develops, tracks, and reports on project plans, including project risks, ensuring internal and external team alignment. The Project Manager also acts as the client account manager with end-to-end ownership of the client account, balancing client satisfaction and project financial performance. The Project Manager maintains a thorough understanding of existing agreements and client profile, and identifies and grows new business opportunities within the program.
Responsibilities include, but are not limited to:
Project manager
Develop and track project timelines. Maintain up to date project schedules and identify and escalate delays. Coordinate cross-functional program deliverables - ensure plans are aligned across internal and external teams and escalate gaps or discrepancies. Project risk management - identify, track, and escalate risks. Maintain and report on a program risk register. Project health management and reporting - Maintain project and client dashboards including key performance metrics, risks, and gaps between internal plans and contractual commitments. Routinely report to department and company management. Client communication – act as the primary point of contact for clients, represent client needs in internal planning discussion, and communicate project timing, scope, and progress to clients Proactively Schedule, plan, and lead internal and external project meetings, including governance reviews (JSC, internal strategic review) and technical discussions, ensuring effective communication and decision making.Account manager
Maintain a detailed understanding of client agreements (MSAs, CDAs, QAAs). Proactively escalate risks and gaps in meeting contractual obligations. Partner with BD to understand client profile, both business profile (product portfolio and program status, business trends) and team characteristics (who are key decision makers, key influencer within teams, team mindset). Understand and help internal teams deliver on client priorities Be curious - ask to understand about client plans, status, opportunities, and feedback. Identify and escalate new business opportunities with each client to increase our footprint within clients’ supply chains (new programs, expanded scope). Educate clients on Pyramid’s capabilities, offer value added services and author change orders and new proposals for existing clients, as needed. Track project financials and work with finance and business development to monitor budgets, change orders, and client billingQualifications:
6 years of experience in project management within a biotech, pharmaceutical, or CMO setting. CMO client project management experience strongly preferredExcellent written and verbal communication skills with demonstrated experience in communicating with technical, business, and executive team membersAbility to work cross-functionally within internal and external teams to drive project successSelf-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment. Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfactionBachelor Degree in Biotechnology, Biochemistry, Bioengineering or similar preferred.PMP Certification a plusScientific experience and education and experience operating within GMP regulated manufacturing facilities are preferred Read Less