Spherion is now recruiting for Senior level Biotech Quality Assurance Specialists with a focus in Audits and Inspections for a rapidly growing cGMP facility located in College Station, TX. This position will be focused on supporting all audit duties and ensure regulatory compliance with all applicable quality policies and site SOP’s. If you are looking for a long-term rewarding career in QA, with a company offering a positive work culture and advancement opportunities then apply or reach out to us today!

Perks & Benefits:

• Long-term direct hire position
• Company offers full benefits (health, dental, vision, & 401k with matching), & PTO
• Variety of advancement opportunities
• Rewarding work involved in the making of life-saving drugs
• Relocation assistance for qualified candidates

Responsibilities:

• Collaborate with management to provide regular mentorship and coaching to peers in the application of GMP principles and the rationale behind those principles.
• Quality Assurance support in conducting internal audits to determine suitability, effectiveness, and compliance with applicable standards and regulations
• Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
• Ensure the company Internal Audit program complies with all regulatory standards and internal audits are executed annually.
• Execute audit strategy and lead process audits.
• Provide ongoing GMP guidance to other departments, such as, Manufacturing, Facilities & QC, Warehouse & Validations.
• Aid Site Readiness Preparation for Regulatory Inspections.
• Support Lessons Learned from audit/inspection findings to benefit other sites
• Review audit report from internal audits

Required Skills:

• Excellent oral and written communication skills, interpersonal and organizational skills.
• Strong leadership skills and ability to set performance goals and provide input to departmental objectives.
• Excellent multitasking and prioritization skills.

Qualifications:

• Bachelor’s degree in a science-related field AND 6-8 years of related work experience OR
• Associate’s degree AND 5 years or more of related work experience
• At least 4 years of cGMP experience in a Quality/Compliance role.

Apply now!

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. No one works harder for you than Spherion.

Work Hours:

Monday-Friday 8am to 5pm with ability to work overtime as needed.

Job Type: Full-time

Pay: $70,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• College Station, TX: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Education:

• Bachelor's (Preferred)

Experience:

• CGMP: 4 years (Preferred)
• biopharmaceutical industry: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)
• Night Shift (Preferred)
• Overnight Shift (Preferred)

Work Location: One location

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