The Quality Assurance Assistant will report to the Director of Quality Assurance and will be integral in maintaining Emery Pharma’s quality management system to ensure that the company complies with all internal and external quality standards. This QA assistant position is ideal for scientists with 2+ years working in a GLP/cGMP regulated environment, interested in transitioning into the field of quality assurance. This position will also be part of a diverse team of analytical and bioanalytical chemists, synthetic chemists, and microbiologists to maintain GLP/cGMP compliance in the laboratory and projects.
The Quality Assurance Assistant will support the Director of Quality Assurance with maintaining the quality system within Emery Pharma. Tasks include, but are not limited to, the following:
- Writing and maintaining SOPs and other quality documents.
- Maintaining equipment and instrument logs.
- Maintaining the training program.
- Maintaining the vendor qualification program.
- Ensuring the qualification and calibration status of all equipment and instruments.
- Helping to maintain order and cleanliness in the laboratory environment.
- Contacting and scheduling vendors to perform calibrations, qualifications, and/or preventative maintenance of equipment and instruments and any repairs throughout the facility.
- Working and assisting with project directors on regulated projects.
- Writing any deviations, non-conformances, CAPAs, OOS’s, and laboratory failures.
- Working with business development and quality assurance groups to ensure effective communication with lab scientists.
- Assisting and/or taking part in any internal and external audits.
- Assisting in R&D research activities.
- Helping troubleshoot and resolve any problems within day-to-day lab operations.
- Maintaining compliance with safety regulations.
- Participating in company/team meetings.
- Participating in educational opportunities, seminars, and workshops.
- Working interactively with other company functions to help achieve the company’s vision.
- 2+ years’ experience in a GLP/cGMP (regulated) laboratory work environment.
- Minimum educational requirement: B.S. degree in Chemistry, Biology, or a related scientific field. M.S. and Ph.D. scientists are welcome to apply as well.
- Ability to work independently as well as in teams.
- Strong communication skills (writing & speaking).
- Flexible, able to multi-task, self-motivated, proactive, and detail oriented.
- Being open and willing to learn new things.
- Experience in any of the following will be considered a plus: familiarity with 21 CFR part 58 and 211, familiarity with ISO 17025, Chromatography (HPLC/UPLC), Mass spectrometry, LC-MS, GC-MS, and/or NMR.
- This a full time onsite position.
- Personal protective equipment provided or required.
- Temperature screenings.
- Required bi-monthly PCR testing.
- Social distancing guidelines in place.
- Virtual meetings as needed.
- Sanitizing, disinfecting, or cleaning procedures in place.
Office Assistant Coordinator
This is an entry level admin assistant position ideal for a recent college graduate or high school graduate with 2+ years of experience.
- Strong communication skills. writing & speaking
- Retail sales experience a plus
- Work interactively with all functions of the company to help achieve the company’s vision
- BS degree or high school degree with 2+ years experience
- Excellent communication skills
Research Scientist -Bioanalytical Chemistry
This is a Research Scientist position and will oversee a team of chemists in their various research and development activities. This position will manage and lead a diverse set of projects and R&D activities of the company with a focus on analytical and bioanalytical chemistry, with exposure to quality management system within a GLP / cGMP environment.
- Strong analytical chemistry skills; including mass spectroscopy, nuclear magnetic resonance spectroscopy (NMR), synesthetic chemistry experience is a plus.
- Experienced in small and large molecule analytical chemistry.
- Formulate research and product development proposals and budgets for the company, setting corporate and departmental goals and priorities related to R&D.
- Responsible for ensuring that the Chemistry department achieves project goals and budget targets in a timely manner.
- Foster close cooperative relationships with all departments in the company. Work with Business Development team and Senior Scientists to develop proposals for clients.
- Support Quality Assurance to ensure all standard operating procedures are of high quality and are readily available for analysis.
- Supervise all study activities, with the chemistry team in terms of study initiation, data reporting and processing, and site management. Monitors adherence to protocols and study timelines.
- Work interactively with all functions of the company and with Senior Scientists to help achieve the company’s vision.
- Minimum of 3-5 years’ experience in R&D or equivalent work experience.
- 1-2 years of progressive management responsibility or equivalent work experience.
- Ph.D. in Analytical Chemistry
- Strong communication skills (writing and speaking)
About Emery Pharma
Emery Pharma is contract research and development laboratory located in San Francisco Bay Area focused on supporting Biotech, Pharmaceutical industry with their bioanalytical, microbiology and cell biology needs. Our mission and vision at Emery Pharma is to help our client-partners “Save Lives and Save the Environment.”
We are prepared to offer the candidate competitive compensation and benefit package, including 90% of health, dental, and vision premiums, 401k retirement plan with company contribution, flexible paid vacation plan, and monthly profit sharing.
Please send resume /C.V. with a cover letter to: [email protected]
Emery Pharma is an equal opportunity employer.