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Human Resource Officer

This is for a part-time position. The officer will develop and manage Inventprise's HR department, and oversee all the various personnel management functions. In addition, the officer will serve as the main advisor to management regarding all human resource matters.

Primary Responsibilities:

  • Develop the HR department
  • Develop and implement strategic HR goals
  • Assist in budget planning, staffing
  • Ensure compliance of all HR functional areas
  • Advise on HR issues and matters (recruitment, placement, position management, employer and labor relations, etc)
  • Representing managements views and decisions on HR matters
  • Promoting teamwork, open communication

Key Qualifications:

  • Strong HR cross-domain knowledge : recruiting, compensation, benefits, employment law, learning and development, employee relations
  • Strong financial and operational business acumen
  • 5-7 years of experience in HR generalist roles preferred
  • Professional in Human Resources (PHR) preferred
  • Bachelor's degree in Human Resources or Management.


Quality Assurance in-charge

This is for a full-time position. The person will be responsible to maintain regulatory compliance of the facility used for development and manufacturing Phase I and II clinical trial material. Responsibilities include issuance of GMP documentation including manufacturing batch records, Standard Operating Procedures and logbooks. Maintain all logs and files associated with documentation issuance process. Review of executed manufacturing batch records and release of product batches. This position provides QA support for the manufacturing of developmental bulk product to ensure compliance with the principles and guidelines of current Good Manufacturing Practices. This position actively partners with manufacturing operations and auxiliary support groups. The person will be responsible to maintain regulatory compliance of the facility used for development and manufacturing Phase I and II clinical trial material. Responsibilities include issuance of GMP documentation including manufacturing batch records, Standard Operating Procedures and logbooks. Maintain all logs and files associated with documentation issuance process. Review of executed manufacturing batch records and release of product batches. This position provides QA support for the manufacturing of developmental bulk product to ensure compliance with the principles and guidelines of current Good Manufacturing Practices. This position actively partners with manufacturing operations and auxiliary support groups.

Primary Responsibilities:
  • Development and maintenance of GMP documentation in support of manufacturing operations
  • Responsible for issuing batch production records and associated supporting documentation
  • Maintain logs and files associated with documentation issuance process equipment use log audits, communicating observations and driving audit closures
  • Manage and maintain Companies Quality Management System Database
  • Scan and file executed batch records and documentation for long term storage.
  • Actively partner with manufacturing operations and auxiliary support groups
  • Author and revise quality documents, assist other departments as needed
  • QA review of executed batch records
  • Perform Line clearance activities as required
  • Perform Change Control and maintain Change Control log and coordinate approval process as required
  • Lead investigation activities and participate in the determination of root cause, corrective action implementation, and monitoring of corrective action effectiveness
  • Initiate, assess, approve, track and trend deviations and CAPA
  • Act as a training officer
  • Act as a safety officer
  • Write validation documents and perform validation and qualification activities
  • Co-ordinate calibration activities and maintain calibration log books/database
Key Qualifications:
  •  B.S. degree in health science or related field
  • 8-10 years of relevant Quality Assurance experience in executing, developing, and/or administrating GMP quality programs in GMP biotech and/or pharmaceutical environments.
  • Experience supporting manufacturing operations is preferred.
  • Experience of working in Biological / Cell Culture industry preferred
  • Experience in Facility, utilities qualifications and maintaining compliance status
  • Knowledge of OSHA regulations
Key Skills:
  • Proficiency with Microsoft applications: Outlook, Word, Excel, Project, and PowerPoint
  • Strong written and oral communication skills required
  • Excellent interpersonal skills and the ability to communicate well orally and in writing
  • Able to perform functions in accordance with cGMP guidelines
  • Ability to multi-task in a dynamic environment with changing priorities
  • Self-motivated and driven to independently accomplish goals and objectives
  • Understands the needs of key collaborators and customers, and interacts effectively intra- and interdepartmentally to achieve alignment and consensus.
  • 2-3 years of experience of all Quality Assurance responsibilities
  • Knowledge of basic documentation control principles

Quality Control Specialist

This is for a full time position. We are looking for a motivated and skillful individual with a MS degree in Biotechnology, Biochemistry, Microbiology or Cell Biology with 1-3 years of experience (or BS with 3-5 years) to join our quality control group as a Quality Control Specialist . This is an exciting opportunity to contribute to the success of both external as well as internal projects in our pipeline

Primary Responsibilities:
  • Perform Analysis of: Incoming raw materials, in process products, finished products as per Quality Control Specifications
  • Plan, organize, and execute protocols, according to high scientific standards, under minimal supervision following GLP and GMP guidelines
  • Work independently as well as part of a team to perform a variety of assays according to current written protocols
  • Maintain accurate and detailed laboratory notebook and documentation according to regulatory guidelines
  • Effectively understand the meaning of assay results and be able to relay them to other team members
  • Identify any deviations in assay results and troubleshoot for potential causes when applicable
  • Periodically present results, and summarize progress to team members
  • Intellectually contribute to group goals by staying current with scientific literature and state-of-the-art methodology
  • Effectively prioritize tasks to meet goals and drive projects to completion according to timelines
Key Qualifications:
  • Good aseptic technique and proficiency handling microbial cultures
  • Experienced or knowledgeable in working in a regulated cGMP environment
  • Hands on experience with chromogenic, chemical and/or biological assays
  • Knowledge of HPLC principles and techniques
  • Assay validation or qualification experience
  • Excellent verbal and written communication skills
  • Proficiency in computer systems and Microsoft office software
  • Ability to strive in a fast-paced, creative, and goal-oriented environment


Environmental Monitoring Technician

This is for a full-time position. We are looking for a motivated and skillful individual with an Associates or Bachelors degree in Biotechnology, Microbiology or with an emphasis on Life Sciences to join our quality control group as an Environmental Monitoring Technician. This is an exciting opportunity to contribute to the success of both external as well as internal projects in our pipeline.

Primary Responsibilities:
 
  • Environmental Monitoring of laboratory and Clean Rooms and facility as per cGMP requirements
  • Bacterial/Fungal Sterility Testing and Analysis (Aerobic and anaerobic)
  • Plan, organize, and execute protocols under minimal supervision following GLP and GMP guidelines
  • Work independently to perform routine tasks according to current written protocols
  • Maintain accurate and detailed documentation according to regulatory guidelines
  • Periodically present results and summarize progress to team members
  • Intellectually contribute to group goals by staying current with scientific literature and state-of-the-art methodology
  • Effectively prioritize tasks to meet goals and drive projects to completion according to timelines
  • Flexibility to assist in other tasks as required
Key Qualifications and Skills:
  • Associate Degree / B.S, in Microbiology or biological sciences
  • Good aseptic technique and proficiency handling microbial cultures
  • Experienced or knowledgeable in working in a regulated cGMP environment
  • Familiarity with Environmental Monitoring principles
  • Excellent verbal and written communication skills
  • Proficiency in computer systems and Microsoft Office suite
  • Ability to strive in a fast-paced, creative, and goal-oriented environment
  • Knowledge of cGMP and FDA requirements

You can email your updated resume to jobs@inventprise.com


Last Updated 13-Feb-2018
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