This position performs as QA analyst in the area of quality assurance oversight of operations, production, process and equipment systems and validations at the Bioscience Laboratories Irvine facility.
This position is responsible for one or more of the following duties or activities:
- Quality Assurance oversight of operational activities, production, and validations and Technical Services projects, ensuring that QA systems and manufacturing/engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration.
- Serving as the QA representative on validation and technical services projects.
- Reviewing and approving as Quality Assurance site process and equipment validation documentation representative, including protocols, deviations, and final reports.
- Supporting change control activities associated with processes and equipment validations.
- Managing the review/approval of DS development master batch records, executed batch records, manufacturing data, and validation and technical reports.
- Maintain a clean and organized work area.
- Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
- Perform all assigned duties according to departmental SOP’s and cGMP’s.
- Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
- Complete and remain current with all required cGMP and safety training.
- Perform other duties as assigned.
Incumbent has full authority to make decisions and/or take actions required to carry out job duties. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements, and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Allergan is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), OSHA, CDC, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
BS degree in Biology, Chemistry, Biochemistry or a closely related discipline (or equivalent years of experience).
Essential Knowledge, Skills & Abilities:
- The ability to comprehend processes in short time frames, coupled with the need to effectively communicate verbally and in writing.
- Development of problem-solving approaches that can be applied to multiple functions within the DSO
- Proven ability to generate results.
- Ability to be an effective and active teacher and mentor
- Ability to interpret multiple standards and apply to department activities.
- Process and results oriented with the ability to lead cross functional teams and solve key problems
- Strong analytical skills including proficiency in the use of computer applications and office automation
- Exellent interpersonal and verbal/written communication skills
- Desire to take on increased levels of responsibility
- Ability to travel about 5%
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced