The QA Compliance Associate II will assume responsibilities associated with the process for the internal/external audit program, training, document review and support  a GMP Quality Management System to ensure compliance to regulatory and internal requirements.  This appointee will be responsible for working closely with Wacker Biotech US Management and Departmental staff in support of the Quality Management System.  This person may support QA operational functions as needed.

Job Responsibilities:

• Ensure compliance with all WBU policies and procedures in addition to all federal/state/local/global and pharmaceutical laws and regulations.
• Supports investigations, deviations and provides metric collection for timely resolutions to exceptions events, out of trend events, facilities and document Risk Management activities (e.g. FMEA.)
• Assists with planning and conducting internal/external compliance audits. Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Evaluates, analyzes and trends quality indicators.  Then prepares reports of quality operations, productivity as well as monthly quality metrics.
• Actively participates in continuous improvement initiatives and assures quality compliance.
• Develops new QA training program and provides training to departmental personnel.
• Support QA operations to release materials and drug substance/drug product.  Including but not limited to data review, batch record review, etc.)
• Support reviews of validation activities.

Job Qualifications:

• BA/BS in a scientific discipline with 3+ years' experience in biotechnology or pharmaceutical industry or MS with 2+ years of experience
• Regulated industry experience required and Quality Assurance/compliance experience  required.
• Requires thorough knowledge of GMP's and compliance
• Working knowledge of FDA regulations
• Interprets compliance requirements for incorporation into company systems/procedures
• Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site.
• Detail oriented and strong communication skills.
• Ability to work in a high pace environment.
• Critical thinking and problem-solving skills.
• Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms, and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is a plus.

Preferred:

• Experience in working within document control systems is preferred.
• Experience with Electronic Document and Quality Management Systems preferred
• Work with various user groups to facilitate auditing and training processes.
• Technical writing and problem-solving skills

The anticipated salary range for candidates who will work in San Diego is $81,000.00-95,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi state employer and this salary range may not reflect positions that work in other states.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement

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