Sr. Quality Assurance Specialist

Bachem Holding AG; Vista (CA); On-site; USD 97,000 - 134,000; Full time

Job summary

Bachem Americas in Vista, California is seeking a Sr. Quality Assurance Specialist to advance GMP systems, review documentation, and guide QA activities across sites.

You will lead real time batch record reviews, support audits, improve quality systems, and train teams on GMP practices. A strong background in organic chemistry or related field and 4–6 years of GMP QA experience are required, including ISO7/ISO8 environments.

Qualifications

• Bachelor's in organic chemistry or related field required or
• Master's in organic chemistry or related field preferred
• 5+ years GMP manufacturing experience required
• 7 years GMP exp with QA document control/validation preferred
• 4-6 years QA experience required
• Experience with ISO7/ISO8 environments and real time batch review
• Experience with internal audits and regulatory agencies preferred
• Excellent written and oral communication skills
• MS Office skills: Word, Excel, PowerPoint

Responsibilities

• Perform duties pertaining to QA specialist levels I–III and more.
• Support real time batch record review and electronic release decisions.
• Suggest improvements to quality systems and SOPs using LEAN GMP.
• Review and approve GMP documentation including BPRs, protocols, reports.
• Analyze, trend data and assist in investigations (OOS) and changes.
• Collaborate with other sites to close quality records and documents.
• Lead GMP audits and provide guidance to other departments.
• Assist with customer/authority audits and SOP writing.

Skills

MS Office suite

Communication skills

LEAN GMP knowledge

Education

Bachelor's Degree in organic chemistry or related field

Master's Degree in organic chemistry or related field preferred

Bachelor's Degree in a science related field + 5 years GMP exp

Associate's Degree in a science related field + 7 years GMP exp

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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The Sr. Quality Assurance Specialist fulfills a critical role in Quality Assurance. This individual will contribute an advanced level of understanding of GMP system improvements, technical documents, and review of GMP documentation and reports. This individual must also provide GMP and related guidance, data analysis, and technical review of QC data. in some instances, this role may act as the deputy for the Manager, Quality Assurance.

What you will do

• Perform all duties pertaining to a QA specialist I, II, III, in addition to those listed below.
• Support real time batch record review in a timely manner and with high accuracy, performing usage decisions in electronic batch release systems.
• Suggest and implement improvements in quality systems and SOPs taking into account LEAN GMP approaches.
• Reviewing and approval of all GMP documentation, which includes BPRs, validation protocols, data, reports, etc.
• Reviewing, analyzing, and trending data to extract relevant information.
• Work closely with other functions and sites to close out quality records, investigations e.g., OOS, and approval of documents and changes e.g., MBPRs, analytical procedures, protocols, reports, and specifications/global specifications.
• Suggests/recommends and implements new policies and procedures to improve existing processes and products.
• Problem resolutions with GMP systems as well as guiding on GMP topics.
• Be an active part in increasing the quality culture in the organization e.g., by guidance and training of other departments and sites.
• Perform GMP audits for internal operations, GMP compliance improvements and provide GMP compliance guidance to other departments and BAM Sites as needed.
• Support actively and able to take the lead in customer/authority audits. Writing new and revising current standard operating procedures (SOPs), specifications, etc. In addition, provide technical assistance on production and quality systems documents.

Qualifications

• Bachelor's Degree in organic chemistry or related field required or
• Master's Degree in organic chemistry or related field preferred
• Bachelor's Degree in a science related field and a minimum of 5 years' experience in a GMP manufacturing setting required or
• Associate's Degree in a science related field and a minimum of 7 years' experience in a GMP manufacturing setting required
• 4-6 years experience in Quality Assurance required
• 4-6 years experience with GMP document control, validation, qualification and calibration preferred
• 4-6 years Ability to work in ISO7 and ISO8 control environment and support real time batch record review required
• 4-6 years experience in internal auditing as well as working with regulatory agencies preferred
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask and work in 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 environment.
• Certified Quality Process Analyst - ASQ preferred or
• CQA preferred or

Annual Salary Range: $97,174.20 - $133,614.80

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

AtBachem, you'll find a diverse, multicultural team. The(a)in the job title stands forall. We welcome applications from all candidates. What matters are your skills and motivation - regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.