Boehringer Ingelheim QA Jobs – Microbiology & Biology Candidates Apply
Boehringer Ingelheim QA Jobs Boehringer Ingelheim job opening. Applications are invited for QA Post Vacancy. Microbiology & biology candidates are invited for the post of Senior Associate, Quality Assurance. Boehringer Ingelheim QA Jobs. Interested candidates may check out all the details on the same below:
Job Title: Senior Associate, Quality Assurance-202957
Location for Boehringer Ingelheim QA Jobs: Americas-US-CA-Fremont
Requirements for Boehringer Ingelheim QA Jobs:
- Bachelor’s Degree in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation) plus two (2) years of Quality Assurance experience on the floor in areas listed above
- In lieu of a Bachelor’s Degree, a High School Diploma will be considered with a minimum of four (4) years quality pharmaceutical industry experience with cGMPs in areas described in this profile.
- Minimum of intermediate knowledge of relevant regulations and guidances. (i.e. cGMPs, SOPs, Protocols).
- Good attention to detail important
- Good conflict resolution and negotiation skills helpful.
- Good organization skills needed.
- Requires good verbal and written communication skills; good interpersonal skills.
- Must be able to work in a team environment
- Strong organizational skills.
- Strong problem-solving skills.
- Ability to identify and escalate issues when necessary.
- Physical Demands / Surroundings – The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds.
- The work environment is dependent upon the area assigned. For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to.
- Visual Demands – Must be able to read and see clearly. Employees assigned to ILP will be required to participate and have acceptable results from vision testing including color-blindness.
- Temperaments/Mental Requirements – Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
Attendance / Schedule – Attendance requirements are based on BIFI general attendance policies.
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Description:
Responsible for the tactical execution of quality assurance oversight activities of the assigned area which may include oversight of any area of the business responsible for adhering to current good manufacturing practices (cGMPs) including warehouse, manufacturing processes, inspection, batch record review, batch disposition, new product introduction/product transfer, and QC laboratories. This includes timely identification of events impacting the Quality of products and processes evaluate situation for potential impact, work with junior staff to assess the event, and notify appropriate senior staff or management for further assessment as needed. QA oversight responsibilities include creating and/or revising SOPs, ensuring adherence to SOPs and requirements, proper change management, supporting corrective action and preventive action plans (CAPA)/Deviation management, and to ensure documentation and/or investigations meet BIFI and regulatory standards. Oversight is assured through close attention to activity execution close to the assigned area and mentoring of junior staff including consistent support (i.e., Cell Culture, Purification, Formulations, Filling, other Technical Areas, Laboratories, etc.) This also includes identification of potential continuous improvement ideas. Provides strong quality oversight and consultation to ensure compliance with cGMP’s, regulatory, industry, and corporate requirements.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
Duties & Responsibilities:
- Responsible for executing the tactical operations required to assess, evaluate, and review on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation.
- Provides guidance for assigned area to ensure compliance with all applicable regulations and SOPs and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business.
- Identifies and reports deviations, as appropriate. Supports execution of remediation/CAPA activities required to continue operations or move a process to the next milestone. Supports investigation team to identify root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
- May be required to escalate critical issues to the senior management team based on severity of the issue.
- Responsible for coordinating tasks associated with quality oversight of the change management system for the assigned QA area. This includes verifying changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.
- Performs technical review of documentation during and post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved prior to submitting to the next step for
- Approval and Release and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
- Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI’s Quality Systems. May attend project team meetings to support QA guidance and oversight to such improvements. May utilize Yellow-Belt skills to support process improvement initiatives via the BPE program.
- May be asked to support internal or external inspections.
