Product Development Research Associate (qPCR)
Career Title: Product Development Research Associate (qPCR)
Career Description: International Clinical Diagnostics Company focusing on the development of molecular diagnostic kits is looking to identify and hire several Research Associates to join their growing Product Development Team.
The qualified professionals will be responsible for but not limited to:
Working within a team environment to plan, conducting and analyzing experiments leading to validation of new molecular diagnostic tests.
Participates constructively in decision making that will impact the performances of the final product.
Developing, Optimizing and Validating molecular assays.
Planning and executing simple experiments independently.
Performing bench work according to internal quality standards, document accurately the results and archive them accordingly in order to facilitate downstream work.
Maintaining strict laboratory notebooks and research records.
Participating in the evaluation and creation of new methods and procedures under the direction of the Director of Product Development.
Preparing technical reports, summaries, protocols and quantitative analysis.
Participating in the creation of all necessary documentation to support product manufacture, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols.
Maintaining high level of professional expertise through familiarity with scientific literature.
May be responsible for identifying patentable inventions.
Career Requirements:
Bachelors degree in Molecular Biology or related life science with 4-6 years of related industry experience, or Masters degree with 3-5 years of industry experience.
Proven hands on INDUSTRY experience with assay development, optimization and validation.
Proven hands on INDUSTRY experience with molecular techniques such as qPCR, MSP, DNA extraction and modification.
Previous experience with Laboratory Information Systems, preferred.
Ability to effectively present information and respond to questions from management, clients, auditors and internal customers.
Knowledge of quality systems and quality system regulations.
Knowledge of ISO 3485 and ISO 9001-2008 are a PLUS!
Location: Orange County – CA.
Annual Compensation: $25.00 – $31.25/hour D.O.E.
Additional Compensation / Benefits: Contract to Hire
Apply: Please attach your resume and name of the opportunity:careers@innovativescientific.com
Cleaning Validation Engineer
Career Title: Cleaning Validation Engineer
Summary: 11 Billion Dollar International Nutritional Supplements company specializing in the Research, Development and Manufacturing of nutritional supplements is looking to identify and hire a Cleaning Validation Engineer.
This is a Monday-Thursday work week (4/10′s).
Responsibilities: Develop, and execute equipment and cleaning validation document qualifications/validations to ensure that products produced are proven to be reliable, safe, and effective prior to release.
Manage and maintain qualification document database; archiving of all QA documentation and maintenance of the Nutrilite Master Validation Plan.
Develop and execute Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), Process Validations (PVs), and Cleaning (CV) and Sanitization (SAVPs) Qualifications under the direction of a Validation Engineer as required to validate equipment, processes, and software used in the testing, processing, storing, and distribution of OTC drug products.
Assists in investigations and resolutions of protocol failures / deviations.
Maintain and coordinate master validation plan / master equipment lists.
Lead, mentor, train and act as knowledge base to individuals involved in executing companies validation program as appropriate.
Manage and meet established project priorities.
Balance numerous responsibilities, including multiple validation projects and database maintenance within the PQI validation group.
Maintain an established Validation Sharepoint site in coordination with archival databases.
Career Requirements: Bachelors degree (Chemical Engineering or related discipline) and 3 – 5 years of hands-on experience in the validation of pharmaceuticals, food, dietary supplements or other FDA regulated product; experience with Beauty and Personal Care OTC industry desired.
Experience in developing and executing protocols in the areas of equipment, cleaning, sanitization, packaging and process.
Strong computer skills and functional experience with the following software: Versa Image, CATSWeb, Sharepoint and all other Microsoft Office Suite products.
Must be flexible and able to effectively manage multiple validation and process improvement projects.
Mission critical competencies: Leadership / Initiative, Customer Focus, Communication, Validation Science, Project Management, Problem Solver / CAPA, Certification / Industry Engagement, Regulatory Knowledge, Manufacturing Knowledge / Experience.
Location: Orange County, CA
Compensation: $40.00 – $45.00/Hour
Apply: Please attach your resume and name of the opportunity:careers@innovativescientific.com
Quality Control Supervisor
Career Title: Quality Control Supervisor
Summary: International Pharmaceutical Corporation focusing on the Research, Development and Manufacturing of niche generic drugs is looking to identify & hire a Quality Control Supervisor to join their growing team of QC professionals.
This is a DIRECT HIRE career opportunity with excellent benefits.
The qualified QC Professional will supervise the analytical testing of pharmaceutical excipients, active substances, in-process materials, and finished products.
Responsibilities will also include but are not limited to:
- Plan and coordinate the analytical work to meet timeliness of releasing commercial and R&D finished product, raw material, stability study, cleaning verification and method validation.
- Effective use internal resources to support raw material release, in-process material and finished product testing.
- Provide technical guidance to junior chemists for trouble shooting.
- Develop training programs to meet GMP requirements.
- Provide budgetary estimates for laboratory-related expenses.
- Responsible in generating laboratory investigation and deviation regarding OOS, OOT or aberrant results.
Required Knowledge and Skills:
- Bachelors and/or advanced degree in Chemistry, Biochemistry or related sciences.
- A Minimum of 5 years of hands on pharmaceutical industry experience.
- 1-2 years of leadership experience within a QC Laboratory (e.g. Senior Chemist, Lead, etc…).
- Experience in maintaining a GMP / FDA compliant laboratory.
- Excellent people skills are mandatory.
- Strong familiarity with cGMP / FDA & DEA regulations.
- Excellent communication skills to include: Verbal, Written & Computer.
Location: Orange County, CA
Compensation: $33/hr -$38/hr
Apply: Please attach your resume and name of the opportunity:careers@innovativescientific.com
