Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior work experience ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior work experience ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED required. * Associate's or Bachelor's degree preferred. * 4-6+ years of relevant experience required, with a strong ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED required. * Associate's or Bachelor's degree preferred. * 4-6+ years of relevant experience required, with a strong ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years preferred.
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years preferred.
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior work experience ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior work experience ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required. * Prior ...
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years preferred.
Documentation Review (Batch Record, Logbooks, etc.) * High school diploma or GED is required. Associate or bachelor's degree preferred. * 1-2 years' work experience required; 2-5 years preferred.
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED required. * Associate's or Bachelor's degree preferred. * 4-6+ years of relevant experience required ...
Documentation Review (Batch Record, Logbooks, etc.) Qualifications * High school diploma or GED required. * Associate's or Bachelor's degree preferred. * 4-6+ years of relevant experience required ...
Prior experience performing or verifying line clearances, room clearances, and/or batch record review required. * Familiarity with deviation management, root cause analysis, and execution of ...
Prior experience performing or verifying line clearances, room clearances, and/or batch record review required. * Familiarity with deviation management, root cause analysis, and execution of ...
Specialist Manufacturing Process Owner - Upstream / Downstream / Services
Holly Springs, NC · On-site
... Batch Record (EBR) testing support. * Partner with Manufacturing Operations to support reliable ... Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.
Specialist Manufacturing Process Owner - Upstream / Downstream / Services
Holly Springs, NC · On-site
... Batch Record (EBR) testing support. * Partner with Manufacturing Operations to support reliable ... Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.
Executed Batch record review and approval * Logbook review and approval * Deviation Triage Record guidance and generation * Routine facility walkthroughs * Facility response for work compromising ...
Executed Batch record review and approval * Logbook review and approval * Deviation Triage Record guidance and generation * Routine facility walkthroughs * Facility response for work compromising ...
Document Control Specialist (QA)
Durham, NC · On-site
$30 - $40/hr
Issue and reconcile batch production records and logbooks; maintain accurate archiving (electronic and physical). * Support document retrieval and record review during internal and external audits ...
Quick apply
Document Control Specialist (QA)
Durham, NC · On-site
$30 - $40/hr
Issue and reconcile batch production records and logbooks; maintain accurate archiving (electronic and physical). * Support document retrieval and record review during internal and external audits ...
Manufacturing Quality Assurance Specialist
Durham, NC · On-site
$43.08 - $80/hr
Review and approve master and executed batch records to ensure compliant clinical and commercial production. * Partner with manufacturing teams to ensure consistent, compliant processes aligned with ...
Manufacturing Quality Assurance Specialist
Durham, NC · On-site
$43.08 - $80/hr
Review and approve master and executed batch records to ensure compliant clinical and commercial production. * Partner with manufacturing teams to ensure consistent, compliant processes aligned with ...
Manufacturing Quality Assurance Specialist
Durham, NC · On-site
$43.08 - $80/hr
Review and approve master and executed batch records to ensure compliant clinical and commercial production. * Partner with manufacturing teams to ensure consistent, compliant processes aligned with ...
Manufacturing Quality Assurance Specialist
Durham, NC · On-site
$43.08 - $80/hr
Review and approve master and executed batch records to ensure compliant clinical and commercial production. * Partner with manufacturing teams to ensure consistent, compliant processes aligned with ...
Manufacturing Quality Assurance Specialist
Durham, NC · On-site
$43.08 - $80/hr
Review and approve master and executed batch records to ensure compliant clinical and commercial production. * Partner with manufacturing teams to ensure consistent, compliant processes aligned with ...
Manufacturing Quality Assurance Specialist
Durham, NC · On-site
$43.08 - $80/hr
Review and approve master and executed batch records to ensure compliant clinical and commercial production. * Partner with manufacturing teams to ensure consistent, compliant processes aligned with ...
Draft, review and approve batch records, deviations, investigations, change controls, and corrective actions. * Identify and implement improvements to increase operational efficiency, product quality ...
Draft, review and approve batch records, deviations, investigations, change controls, and corrective actions. * Identify and implement improvements to increase operational efficiency, product quality ...
Draft, review and approve batch records, deviations, investigations, change controls, and corrective actions. * Identify and implement improvements to increase operational efficiency, product quality ...
Draft, review and approve batch records, deviations, investigations, change controls, and corrective actions. * Identify and implement improvements to increase operational efficiency, product quality ...
Batch Record Reviewer information
See Raleigh, NC salary details
$12.62 - $14.45
1% of jobs
$14.45 - $16.27
15% of jobs
$16.82 is the 25th percentile. Wages below this are outliers.
$16.27 - $18.10
31% of jobs
The median wage is $18.34 / hr.
$18.10 - $19.93
28% of jobs
$19.97 is the 75th percentile. Wages above this are outliers.
$19.93 - $21.75
12% of jobs
$21.75 - $23.58
8% of jobs
$23.58 - $25.41
4% of jobs
$25.41 - $27.23
1% of jobs
$27.23 - $29.06
0% of jobs
$29.06 - $30.89
0% of jobs
$30.89 - $32.71
0% of jobs
$12
$19
$32
How much do batch record reviewer jobs pay per hour?
What is a batch record reviewer?
A Batch Record Reviewer is responsible for reviewing manufacturing and production records to ensure compliance with regulatory standards and internal quality procedures. They verify that all documentation is complete, accurate, and meets Good Manufacturing Practices (GMP) requirements. Their role helps maintain product quality and ensures that any discrepancies or deviations are identified and addressed before product release. Batch Record Reviewers typically work in industries such as pharmaceuticals, biotechnology, and food manufacturing.
What does a batch record reviewer do?
A typical day for a Batch Record Reviewer involves meticulously examining batch records, manufacturing documentation, and supporting data to ensure compliance with regulatory and company standards. Reviewers frequently interact with production staff, quality assurance teams, and sometimes laboratory personnel to clarify discrepancies or gather additional information. Attention to evolving priorities and deadlines is common, especially when batches are ready for product release. This role offers valuable exposure to multiple departments and can serve as an excellent pathway to higher-level quality or regulatory positions within the company.
What skills and qualifications are needed to be a batch record reviewer?
To thrive as a Batch Record Reviewer, you need a keen attention to detail, strong analytical skills, and a solid understanding of Good Manufacturing Practices (GMP), often supported by a degree in life sciences or related fields. Familiarity with electronic documentation systems, quality management software, and sometimes certifications like Six Sigma or GMP training is highly valued. Excellent organization, communication, and problem-solving abilities are important soft skills for ensuring thorough and compliant record review. These competencies are crucial for maintaining product quality, regulatory compliance, and operational efficiency in pharmaceutical or biotech manufacturing environments.
What are popular job titles related to Batch Record Reviewer jobs in Raleigh, NC?
For Batch Record Reviewer jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Batch Record Reviewer jobs in Raleigh, NC look for?
The top searched job categories for Batch Record Reviewer jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Batch Record Reviewer jobs?
Cities near Raleigh, NC with the most Batch Record Reviewer job openings:

Manufacturing Technician I - Sterile Injection - 12-Hr Day Shift 2-2-3
Morrisville, NC • On-site
Full-time
Re-posted 22 days ago
Alcami rating
7.8
Based on 9 frontline employees who took The Breakroom Quiz
Job description
Are you interested in joining our team?
Job Summary
The Manufacturing Technician I (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Manufacturing Tech. I is a key role responsible for executing advanced production tasks involving compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single-use components, ability to troubleshoot, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Technician I performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Tech. I employs acceptable techniques while working in manufacturing environments, including PPE gowning. The candidate must have the ability to learn specific department procedures, have a general understanding of Good Documentation Practices (GDP) and GMP, and follow directions from leadership/peers to ensure manufacturing goals are met.
On-Site Expectations
- 100% on-site position.
- Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm.
Responsibilities
- Learns and executes manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
- Become a subject matter expert (SME) on compounding/filling processes and equipment.
- Performs production processes with adherence to SOPs, batch records, quality standards, and minimally contributes deviations to maintain product quality.
- Conducts in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards.
- Identifies inefficiencies and escalates to area supervision real-time to support continuous process improvement.
- Maintains accurate and detailed production documentation. Documentation is completed legibly with minimum errors and recommendations are escalated to drive document revisions to reduce errors.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Demonstrates technical ability in general manufacturing technologies and utilizes technologies per SOPs and cGMPs.
- Performs in-process sampling, weight checks, and component counting and basic math calculations.
- Performs in-process inspection and finished product visual inspection.
- Performs cleaning of rooms, tools, and equipment before and after use.
- Assists with other manufacturing areas as required.
- Performs activities right first time in areas of material handling/dispensing, compounding, and filling.
- Follows general instructions on routine work and detailed instructions on new projects or assignments.
- Follows all Safety requirements and leads by example a safety-first culture.
- Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.
- Other duties as assigned.
Manufacturing Technologies for Sterile Liquids (including but may not be limited to):
- Equipment and component preparation and sterilization (i.e., filter integrity testing, autoclaving, parts wrapping)
- Compounding
- Vial Washing / Depyrogenation
- Aseptic Filling / Stoppering / Capping
- Lyophilization
- Visual Inspection
- Facility Cleaning/Sanitation
- Documentation Review (Batch Record, Logbooks, etc.)
Qualifications
- High school diploma or GED is required. Associate or bachelor's degree preferred.
- 1-2 years' work experience required.
- Prior work experience in a cGMP pharmaceutical manufacturing environment required.
- Previous experience in dispensing, compounding, aseptic filling, or visual inspection highly desirable.
- Candidates with NC Bioworks certificate will be considered without manufacturing experience.
Knowledge, Skills, and Abilities
- Excellent verbal and written communication skills, works collaboratively in a team environment.
- Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
- Applies job skills, company policies, and SOPs to complete a variety of assignments.
- Strong detail orientation and organizational skills required.
- Strong problem-solving and basic trouble-shooting ability required.
- Ability to perform basic math calculations.
- Ability to read and comprehend detailed written instructions and apply instructions during execution is required.
- Ability to move materials throughout the facility using appropriate methods and equipment required.
- Ability to use the appropriate PPE based on product handling requirements (i.e. PAPR, Supplied Air Respirator, etc.).
- General compounding equipment (pH meters, mixers, stir plates, rigid/soft vessels)
- Single-use solution pathway parts including aseptic connectors and filtration assemblies
- Drug Product fillers including isolators
- Strong attention to detail and the ability to detect minute defects or discrepancies in product appearance.
- Excellent communication and interpersonal skills with the ability to effectively train and certify employees.
- Ability to work independently and collaboratively in a fast-paced environment.
- Flexibility to adapt to changing priorities and support operations at variable capacities. Ideal candidates must readily adapt to variable operations required batch to batch.
- Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is preferred.
Travel Expectations
- Up to 5% domestic travel expected.
Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds and occasionally lift and/or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The employee must have 20/20 vision (with or without corrective lenses) and must possess the ability to pass a color-blind test.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The use of tight-fitting respirators limits facial hair for proper protection. Based on product, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle such as a forklift.
About Alcami
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Durham, NC, US
Year founded
1979