Batch Record Coordinator

4 weeks ago

Rancho Santa Margarita, United States Protab Laboratories Full time

**About Us**: ProTab Laboratories was established in 2004 as a state-of-the-art facility in Southern California with a single goal in mind to meet the ever-changing needs of our customers in a continually changing business environment. ProTab Laboratories offers the flexibility to provide manufacturing services for tablet, capsule, and powder form products as well as high-capacity granulation, milling and blending processes for nutritional and dietary supplements.

**Why Work For Us**:At ProTab Laboratories, our mission is to be our customers’ most valuable asset and we are committed to developing that same relationship with our employees by providing competitive pay, generous benefits, and a positive company culture that values opportunities for professional growth and learning.

Some of our benefit offerings include:

- Medical, Dental, and Vision Insurance (employee coverage is 100% company paid)
- Flexible Spending Accounts for Health Care and Dependent Care
- Company Paid Life and AD&D Insurance
- Company Paid Employee Assistance Program (EAP)
- 401(k) with Company Match
- Company Paid Sick Time, Vacation, and Holidays
- Flexible Work Schedules
- And a lot more

**About the Position**:
The Batch Record Coordinator is responsible for the creation, assessment, and issuance of batch records in accordance with cGMP guidelines.

**Essential Responsibilities**:

- Ensure accuracy and completeness of batch records, including documentation of all manufacturing and testing activities.
- Keep accurate and organized records of batch record review activities and findings.
- Collaborate with production to resolve batch record discrepancies and/or errors.
- Create post production deviation reports.
- Provide support during regulatory inspections and audits by presenting batch record documentation and responding to inquiries.
- Identify areas for improvement in batch record processes and suggest solutions to enhance efficiency and compliance.
- When required, wear personal protective equipment (PPE) such as gloves, safety glasses, masks, face shields, etc.
- Comply with all Company policies and procedures, cGMP regulations, and safety rules.
- Communicate effectively with all levels of management as well as office and manufacturing personnel.
- Other duties as assigned.

**Requirements**:

- 1+ year of batch record experience in the pharmaceutical/nutraceutical or food industry.
- Strong knowledge of cGMP regulations.
- Dependable and punctual with the ability to work a flexible schedule.
- Demonstrated ability to interact with others in a professional, tactful, and sensitive manner.
- Ability to work independently and self-manage and work well as part of a team.
- Intermediate to expert knowledge of Excel.
- Familiarity with Sage100 is preferred but not required.
- Capable of managing multiple priorities and thriving in a fast-paced work environment with strong attention to detail.
- The ability to read, write, comprehend and speak English is required. Fluency in Spanish and/or Vietnamese is a plus
- BA/BS in chemistry and/or equivalent combination of education and work experience.

**Pay Transparency**: In order to comply with equal pay and pay transparency laws in various locations, we believe the target range of base compensation in all locations within the United States for this role is $20.78-$27.84 per hour. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and location.
- To comply with state and federal law and regulations requiring employers to maintain certain records;
- To obtain and verify background check and references, and

Employment History: Information regarding prior work experience, positions held, names and contact information of prior employers and supervisors, and reasons for leaving prior jobs.

If you become employed by the Company, the Company will notify you of additional categories of Personal Information that it collects, receives, and maintains for business purposes.

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