QA Batch Record Reviewer

Position Title: Quality Control Inspector II

Ability to stand for 8-12 hours per day and lift up to 50 pounds

Willingness to work 40–48 hours per week, and up to 60 hours depending on manufacturing demands

100% on site

Job summary:

• Responsible for, but not limited to, inspecting, and receiving human and porcine tissue, batch record review, cleaning, cycle count, product/tissue quarantine, media change and disposition activities.
• Ensures quarantine, receiving, cycle count, cleaning, media change and review activities are performed in accordance with all applicable procedures, regulations, and established specification requirements.
• This position is required to support overall departmental needs such as data trending, audit SME support, documentation updates among other tasks.
• Provide technical support to teams and cross-functional teams to ensure effective operations.
• Proficient in all areas of QC Tissue Receipt.
• This role is also responsible for identifying, coordinating, and implementing 5S and Lean Six Sigma continuous improvements initiatives.
• Supports and partners with cross-functional teams to resolve any issues or nonconformance encountered. Assists in documentation updates and related change controls activities as needed.
• Perform applicable actions for Exception Reports (ERs), CAPAs, Supplier Related ERs, LIR's, Change Controls (ECOs), etc.

Key duties and responsibilities: describe scope:

• Performs receiving and reviewing activities in accordance with applicable procedures.
• Communicates with management and escalates as needed, leads the team by example, build relationships and collaborates cross-functionally.
• Responsible for training, developing, motivating, and counseling of the team strengthening the core and developing new skills.
• Helps in training all employees.
• Quarantine product as deemed necessary for identified non-conforming product. Complete transactions as deemed necessary for acceptable or rejected non-conforming product.
• Provide review and monitoring of area processes and documentation for tasks for completeness and accuracy. In partnership with the area manager, ensures compliance and adherence to procedures. Partner with cross-cross functional departments for ensuring accurate documentation for work and resolution of issues.
• Responsible for tracking and follow-up of issues and updating metrics.
• Maintains 5S and ensure area has supplies needed for the functionality of the team.
• Complete all necessary training on time.
• Perform Cleaning and Cycle Counting as deemed necessary per procedures
• Perform media change as deemed necessary per procedures.
• Active member in other cross-functional collaborative efforts and attends quality tuddles, team meetings, and project meetings.

Key Skills, Experience, and Requirements:

• Adaptability
• Agility and accountability
• Critical thinking and problem-solving
• Strong communication skills
• Goal-oriented, able to lead within a team environment, self-motivated, and able to work with a sense of urgency to meet business needs.
• Strong organizational skills
• Computer proficiency and ability to learn new programs/applications

Job qualifications (minimum requirements):

The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Ability to carry and lift boxes weighing up to 50 lbs.
• Ability to work varied schedule with some potential weekend, early morning or late evening hours, if needed.
• Ability to work with human and porcine raw materials and finished goods specially defined functional areas.
• Must be comfortable working in a lab, warehouse and manufacturing settings.
• Willing to work with potentially biohazardous materials, including cadaveric tissue.
• Ability to walk, lift, bend, squat, stoop, stretch, sit and stand for long periods of time.
• Ability to carryout detailed written or oral instructions.
• Ability to handle a wide variety of tasks under critical time constraints.
• Computer proficiency and scheduling experience required; good writing skills required.

Job Type: Full-time

Pay: $ $24.00 per hour

Benefits:

• Health insurance

Education:

• High school or equivalent (Preferred)

Experience:

• CGMP: 3 years (Preferred)
• batch records review.: 3 years (Preferred)
• pharma or biotech or medical device industry: 3 years (Preferred)
• Change Control: 3 years (Preferred)
• CAPA: 3 years (Preferred)

Ability to Commute:

• Branchburg, NJ Required)

Work Location: In person

Salary : $24