Operations Compliance Specialist

Job Title: Operations Compliance Specialist

Location: San Diego, CA

Duration: 3+ months Temp-to-Hire

Shift: Monday to Friday, 8:00 AM - 4:30 PM

Pay Range: $43.00/hr

Job ID: 371784

About BCforward

BCforward is a leading global IT consulting and workforce solutions firm providing services and support to Fortune 500 and government clients. Founded in 1998, BCforward has grown with our customers needs into a full-service business solutions provider. With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.

Job Description

We are seeking an Operations Compliance Specialist to join our dynamic team. The ideal candidate will have strong experience in cGMP operations, investigations, and technical writing and a proven ability to lead root cause analysis, manage deviations and complaints, and implement CAPAs that prevent recurrence of quality events.

Responsibilities:

• Participate in and facilitate Rapid Response Team fact gathering.
• Author clear, comprehensive investigation reports that document what happened, why it happened, and when it happened.
• Propose effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.
• Deploy Lean, Six Sigma, and SPC tools to address root causes of nonconforming quality events.
• Facilitate cross-functional problem-solving sessions.
• Author SOPs and work instructions to strengthen operational standards.
• Review investigation documentation for Out of Specification, Out of Trend, atypical results, and deviations from regulations, corporate policy, or site procedures.
• Manage timelines for investigations and complaints to ensure on-time reporting and closure.
• Communicate clearly with internal and external clients in both verbal and written formats.
• Apply related SOPs and cGMPs to daily tasks.
• Perform other duties as assigned.

Required Skills & Qualifications:

• Bachelor's degree.
• Minimum 5 years of relevant industry experience in a cGMP environment or comparable pharmaceutical knowledge and experience.
• Minimum 3 years of technical writing in GMP settings, including validation reports, engineering documents, and controlled documents such as SOPs, batch records, and work instructions.
• Proficiency with MS Office and query-based activities, including Pivot Tables, VLOOKUPs, Excel formulas, and PowerPoint presentations.
• Excellent oral and written communication skills.
• Proactive problem-solving and analytical skills with the ability to work under pressure and prioritize.
• Ability to manage several projects simultaneously and reprioritize as needed.

Preferred Skills:

• Lean, Six Sigma, and SPC experience. One year preferred.

Why BCforward?

At BCforward, we believe in advancing lives and careers. When you join our team, you gain access to:

• Competitive compensation and benefits.
• Opportunities for growth with global clients.
• A supportive, inclusive culture that values innovation and people.
• Exposure to cutting-edge technologies and projects.

About Our Commitment

BCforward is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Interested? Apply Now!

If this sounds like the right opportunity for you, please apply with your most recent resume or contact:

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