What are the responsibilities and job description for the Quality Compliance Specialist position at BCForward?
Job Title: Quality Operations Compliance Specialist
Location: 7330 Carroll Rd San, Diego, CA 92121
Duration: 3 months Temp-to-Hire
Shift: Monday to Friday, 8:00 AM – 4:30 PM
Pay Range: $43.00/hr
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.
Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.
BCforward is an equal opportunity employer.
Salary : $43