Quality Assurance Release Manager
Company: Bachem
Location: Torrance
Posted on: June 16, 2022
Job Description:
The Swiss based Bachem Group is a public, innovation-driven
company specializing in the development and manufacturing of
pepTides and oligonucleoTides. As a full service provider Bachem
offers products for clinical development and commercial
applications as well as a comprehensive catalog and exclusive
custom synthesis. With 50 years of experience and subsidiaries in
Switzerland, the United States, the United Kingdom and Japan,
Bachem is the partner of choice for the biotech and pharma industry
worldwide.Bachem. Leading Partner in TidesIn order to continue our
organic growth, we are constantly looking for talent.Your
ResponsibilitiesThe Quality Assurance Release Manager is
responsible for operations related Quality Assurance activities
including review and approval of GMP documents and release of GMP
materials. In conjunction with the Director of Quality Assurance
and VP of Quality, this individual ensures manufacture of drug
substances in compliance with FDA and international regulatory
requirements for research, pre-clinical, clinical and commercial
Active Pharmaceutical Ingredients (APIs).Your Tasks
- Timely release of GMP materials
- Review and/or approval of technical protocols and reports
- Review and/or approval of quality records e.g. deviations,
investigations, CAPA's
- Ensure GMP compliance and continuous improvement of BTO's
quality system
- Write/review/approve standard operating procedures (SOPs),
specifications, etc.
- Support customer & regulatory audits. Participate in responses
to audit observations
- Review and/or approval of trending data
- Review and/or approval of Change Controls
- QA representative in project teams e.g. harmonization of
systems and processes across Bachem sites, implementation of new
systems or processesYour Profile
- Bachelor's Degree in Science related field, Chemical
Engineering, Biology or equivalent
- Minimum of 5 years' experience in a GMP/regulated industry
- Minimum of 3 years in QA management position
- Experience in GMP manufacturing environment, Quality Assurance,
Quality Control
- Experience with 21 CFR Parts 210, 211, ICH Q7
- Experience with GMP document control
- Experience in both internal and external auditing
- Ability to work with regulatory agencies
- Strong technical writing skills
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and
PowerPoint
- Ability to effectively organize, multitask, and work in a
fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused
manner, including keeping management aware of potential issues
- Detail oriented with the ability to troubleshoot and resolve
problems
- Ability to work independently and manage one's time
- Communicate effectively and ability to function well in a team
environmentCandidates for positions as US employees of Bachem
Americas, Inc. ("Company") must be in the process of or fully
vaccinated against the COVID-19 virus and provide the Company with
proof of vaccination as a condition of employment, except for U.S.
employees who request and qualify under applicable law for
disability and religious accommodation from the COVID-19 vaccine
mandate. An applicant who receives an offer of employment from the
Company for a position as a U.S employee will be required to
provide proof of vaccination status, or request and receive a
disability or religious accommodation for which the applicant is
entitled under applicable law, before their first day of employment
or any later deadline specified by the Company in the offer letter.
The Company is an equal opportunity employer and provides
employment opportunities and makes employment decisions without
regard to an individual's disability, religion or on any other
basis prohibited by law.
Keywords: Bachem, Torrance , Quality Assurance Release Manager, Executive , Torrance, California
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