Quality Control Associate Scientist Jobs in Butler, Ohio

Maintain compliance with applicable ICH, GLP, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.

Record data per GxP requirements. Provide peer review of documentation as needed.

At least 1 year of experience in GMP pharmaceutical environment.

Senior Manager Quality Control, Biologics CMC

Perform sampling, testing and release of raw materials and in process testing.

Perform testing as per current approved test method and maintain accurate laboratory records and adhere to cGMP/GDP expectations.

Maintain compliance with applicable ICH, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.

Process environmental monitoring samples including plate enumeration and data entry.

Perform release and stability testing and record data per GxP requirements.

Participate in and may assist in writing laboratory investigations.

Participate in aseptic processing in a clean room environment.

Actively contribute to the maintenance of a clean, safe working environment in the laboratories.

Actively participates in method transfer activities between facilities within the organization or between organizations.

Actively participates in and leads investigation of out-of-specification laboratory results, when required.

Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.

Prepares and executes method transfer protocols, method verification/validation protocols as and when required.

Assists, as and when needed, senior scientists working in the laboratory.

Standardizes API for use as in-house reference standard as assigned.

Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and other analytical techniques as applicable.

Actively participates in investigation of laboratory results, when required.

Assists, as and when needed, scientists working in the laboratory.

Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.

Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor.

Manage GMP/ICH compliant stability programs to ensure product quality and reliability.

Stay updated on regulatory requirements related to analytical testing and quality control and provide guidance on compliance matters.

Perform any other duties as required to support the overall success of the organization and advance our scientific capabilities.

Strong prioritization and decision-making abilities to handle multiple tasks efficiently.

Excellent communication skills to effectively interact with team members, stakeholders, and external partners.

Strong planning and organizational skills to lead complex projects and timelines effectively.

Must understand and apply cGMP requirements applicable to quality control laboratory.

Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.

Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.

Ensure that expired chemicals and reference standards are removed from laboratory area.

Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.

Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device is preferred.

Competitive pay based on experience, plus an annual performance bonus.

Develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory instrumentation.

Experience identifying and defining problems, collecting data, establishing facts, and making scientific-based conclusions is preferred.

Experience in Lab Operations and/or Quality processes/systems in a GMP Lab setting is preferred.

Experience working with Lab Systems or processes such as eLIMs, TrackWise, Non-conformances, and/or Change Control is preferred.

Must understand and apply cGMP requirements applicable to quality control laboratory.

Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.

Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.

Ensure that expired chemicals and reference standards are removed from laboratory area.

Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.

Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

Must understand and apply cGMP requirements applicable to quality control laboratory.

Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.

Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.

Ensure that expired chemicals and reference standards are removed from laboratory area.

Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.

Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

Must understand and apply cGMP requirements applicable to quality control laboratory.

Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and other analytical techniques as applicable.

Actively participates in investigation of laboratory results, when required.

Assists, as and when needed, scientists working in the laboratory.

Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.

Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor.

BS in Chemistry or in a science-related field or equivalent. Three to five years pharmaceutical experience preferred.

Experience with Empower data analysis software is desirable.

Perform peer review of analytical testing documentation and resolve discrepancies.

Complete and/or conduct required training according to the laboratory curriculum.

Maintain laboratory data in an orderly manner in laboratory notebooks, worksheets and documents.

Re-validate microbiological methods. Author technical reports for analytical methods improvement.

Actively participates in method transfer activities between facilities within the organization or between organizations.

Actively participates in and leads investigation of out-of-specification laboratory results, when required.

Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.

Prepares and executes method transfer protocols, method verification/validation protocols as and when required.

Assists, as and when needed, senior scientists working in the laboratory.

Standardizes API for use as in-house reference standard as assigned.

Excellent interpersonal skills with ability to work effectively with individuals at all levels (i.e. Management, CM, Development, etc.)

Apply software testing skills to ensure high quality software in multiple domains

Experience in developing comprehensive and accurate test designs and plans

Experience designing and executing black, white and gray box test conditions

Strong verbal and written communication skills

Experience with a comprehensive set of testing types, including unit, regression, integration, freestyle, and acceptance testing

Must possess strong organization skills

Perform documented methods required for finished product quality testing

Review manufacturing documentation for process deviations

Communicate analyzed results in detailed written reports.

Maintain archive of control sample inventory required for product testing

Maintain accurate and detailed records

Ensure assigned analytical methods are ready to be performed when required including management of reagent and equipment inventory

Supports laboratory management or leads in drafting analytical response/strategy documents.

Supports laboratory management in scheduling activities

Drives execution of method qualification/development & optimization/transfer as governed by protocols and/or under the supervision of senior lab staff.

Performs other job duties as assigned.

5 years experience in the pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.

Possesses working knowledge on process unit operations within a section of the manufacturing process (either upstream, downstream, or fill/pack) as assigned.

Works under general supervision of higher-level scientist or manager.

Applies a working knowledge of related technical disciplines.

Provides technical support for the implementation of onsite biosafety testing of biologics.

Conducts or participates in multiple simultaneous projects that are complex and technically demanding within the area/field of QC.

Initiates, implements, plans, directs, and executes investigations to resolve deviations, understand analytical trends, and/or improve process performance.

Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and other analytical techniques as applicable.

Actively participates in investigation of laboratory results, when required.

Assists, as and when needed, scientists working in the laboratory.

Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.

Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor.

Determine if incoming orders match criteria as stated on the purchase order, and if a problem exists, inform the QC Manager.

Perform miscellaneous duties as assigned by the QC Manager.

Inspect incoming orders to ensure quality of merchandise meets established standards.

Attach scanned labels to corresponding cases.

Resolve any discrepancies that might exist between quantities received and quantity stated on the vendor ASN.

Ability to talk and hear

Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.

Act safely and follow Environment, Health and Safety requirements for site and QC laboratories.

Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.

Excellent oral, written and interpersonal communication skills

Knowledge of Microsoft Office applications, specifically Word and Excel

Experience with and in depth understanding of Microbiology testing (e.g. sterility, bioburden, viability, purity etc)

Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA

Knowledge in LIMS, QTS, SAP, eQMS, MODA, etc.

Excellent effective written and verbal communication and interpersonal skills

Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.

Highly organized and detailed with effective time management skills.

Perform other tasks as needed by laboratory management.

Support quality assurance investigations of product complaints with technical knowledge of the products and analytical instruments.

3-5 years of relevant laboratory experience.

Update and maintain the equipment logbook, electronic sample log, reagent inventory log, and external testing log daily.

Perform peer review of laboratory documentation to ensure compliance with laboratory SOPs and test methods.

Knowledge of GMP, USP, ICH, and other regulatory requirements and experience applying them to work.

Excellent communication skills (oral and written) and data management skills.

Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.

Support QC management in the timely review of data.

Provide on-the-floor mentorship, training and technical leadership for less experienced staff as an individual contributor

BS in Microbiology, Biology or related field and 4-8 years experience in a GMP QC Microbiology lab

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

Performs and documents the analysis of samples following approved test methods

Highly organized and detailed with effective time management skills.

Perform other tasks as needed by laboratory management.

Support quality assurance investigations of product complaints with technical knowledge of the products and analytical instruments.

3-5 years of relevant laboratory experience.

Update and maintain the equipment logbook, electronic sample log, reagent inventory log, and external testing log daily.

Perform peer review of laboratory documentation to ensure compliance with laboratory SOPs and test methods.

Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)

OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)

Strong knowledge of cGMP in a pharmaceutical setting

Strong knowledge in analytical techniques in a QC/commercial setting (e.g. HPLC, dissolution, GC, KF, etc.), including method validation/transfer

Experience with both drug substance and drug product (oral solid dosage forms) testing

Effective communication skills, both verbal and written

Strong problem-solving skills with experience in Root Cause Analysis.

Interacts effectively with business partners to communicate and resolve issues. Understands business requirements of the other functions.

Master/PhD in Chemistry, Biochemistry or related science with a minimum of 5-10 years’ experience in a cGMP (analytical or biology) environment.

Prior experience working in a GMP analytical laboratory with demonstrated proficiency in complex laboratory analysis.

Understanding of compliance requirements and regulatory expectations.

Experience with a broad range of analytical techniques applicable to monoclonal antibodies, including (cell-based) bioassays, qPCR and ELISA methods.

Communicate effectively with cross functional stakeholders and quickly find solutions.

Organize and /or provide advanced training to batch production and quality control team to ensure high manufacturing efficiency and quality standard

Work closely with R&D and setup process to facilitate product troubleshooting and redevelopment transfer from QC to PE to R&D.

Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.

Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development

Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines

Applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals

Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.

Knowledge of Microsoft Office applications, (Word & Excel)

Experience with Laboratory Information Management System (LIMS)

Basic computer skills (data entry and attention to detail) in Microsoft

Excellent effective written and verbal communication and interpersonal skills

Experience in biotech or pharmaceutical industry

Experience leading continuous improvement projects.

Laboratory experience, including HPLC with Empower

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Generous paid time off, including: