Job Title: Senior Quality Assurance Inspector
Duration: 6 MONTHS
Location: Franklin Township, NJ 08873
Anticipated Start Date: ASAP
(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.
Job Type: Contract (40 hrs. a week)
Pay Range: $35/hr-$41/hr
(Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).
Work Schedule:
SHIFT - MON-FRI 8:30AM - 5PM.
Job Description:
Quality Operational Specialist supporting manufacturing department quality-related activities. Candidate should have prior GMP inspection and documentation quality review experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail-oriented in a fast-paced multi-task environment with good oral and written communication skills and can interact with all levels of management and other supporting departments.
* Conduct audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate and pharmaceutical development SOPs
* Perform QA Room Releases, line clearances, equipment releases and AQL inspections as required.
* Provide Quality Floor supports during batch manufacturing by performing routine Quality auditing.
* Provide QA support to Manufacturing for clinical and commercial batches
* Audit of executed Batch Records for compliance with CGMP and provide customer audit responses as required
* Audit of raw materials, facility logs, release data.
* Interdepartmental communication for obtaining information and audit corrections
* Comply with and ensure compliance of the department with Health, Safety and Environmental responsibilities
* Assist with batch investigations as required
* Able to work over the weekend and stay outside business hours if required as direct by the department manager.
* Assist other duties assigned by manager to support the department and business.
Education or Equivalent Requirements:
* High school diploma or equivalent (GED) with 8+ years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing.
Knowledge/Skills Requirements:
* Good understanding of compliance regulations and audit techniques.
* Thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements.
* Full understanding of FDA, CGMP, and DEA regulations pertaining to Pharmaceutical manufacturing
* Good mathematical skills
* Safety procedures associated with department.
* Read and understand MSDS requirements and restrictions.
* Understand procedures related to document control, Quality Assurance and this job function.
* Candidate must have ability to work effectively under high pressure on multiple projects.
* Candidate must have detail oriented with effective oral and written communication skills.
Physical Requirements:
* On average 8 hours day this position requires the ability to work, sit and stand.
* Ability lift up to 15-30 pounds when required to perform the routine assigned duty task.
* Ability to perform the task wearing Personal Protection Equipment (PPE), such as eye glasses, respirator, etc.
WORK ENVIRONMENT/SAFETY CONSIDERATIONS
This position works in a high-pressure, fast-paced manufacturing facility with the QA support requirement to meet multiple deadlines while paying strict attention to details. The position demands responsive and clear oral and written communication and good interpersonal skills. This function will demand a high volume of QA operational support to meet manufacturing schedules during assignments working shifts with occasional weekends and extended hours as required by department and business needs. This position will involve interacting daily with manufacturing, facility, Quality Assurance, and other supporting department groups.
Benefits:
BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.
About BCforward:
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 place to work.
BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.
This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.
Interested candidates please send resume in Word format Please reference job code 233413 when responding to this ad.
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